chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Crohn's disease, Diabetes mellitus
Clinical narrative: Received HPV vaccine in 2007: diagnosed with DM 2007, and Crohn's disease 2015.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2015Us057817, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 560899) website on 12 May 2015 and with a follow-up information received from the Quality Assurance Department (reference number: 370485) on 13 May 2015 with a follow up received from the quality assurance department (QA, reference number: 370485) on 11 Jun 2015. This report refers to an 11-year-old male patient. Historical conditions and current illness were none. Concomitant medications were none. The patient was vaccinated with MENVEO (batch number: M14056) intramuscularly into the right arm on 07 Jan 2015. On the same day after vaccination, the patient's right arm was red and swollen. The patient was given a diagnosis of cellulitis. The patient was treated with Cefdinir for 10 days. The final outcome of the events was complete recovery. The events were reported as non-serious. Seriousness of the event cellulitis was upgraded based NVS-IME list. Causality was not reported. Based on the investigation performed, the QA department stated that MENVEO (batch number: M14056) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 370485) on 13 May 2015: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 370485) on 11 Jun 2015: Updated batch review report.
Age: 37.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of serum sickness in a 37-year-old male patient who received TWINRIX (batch number 3NK9A, expiry date 27th May 2017). On an unknown date, the patient received TWINRIX. On an unknown date, 2 days after receiving TWINRIX, the patient experienced serum sickness (serious criteria hospitalization), pain in arm (serious criteria hospitalization), shoulder pain (serious criteria hospitalization), pain in hip (serious criteria hospitalization), fatigue (serious criteria hospitalization) and change in blood pressure (serious criteria hospitalization). On an unknown date, the outcome of the serum sickness, pain in arm, shoulder pain, pain in hip, fatigue and change in blood pressure were not recovered/not resolved. The reporter considered the serum sickness, pain in arm, shoulder pain, pain in hip, fatigue and change in blood pressure to be related to TWINRIX. Additional information received: Reporter states that he received the TWINRIX vaccine on March 28, 2015 at his place of work by a nurse. Two days after receiving the vaccine he had shooting pain in both arms, shoulders, and hips. Within a week he was feeling fatigue and "could feel his heart beating throughout his body". He contacted his physician and was told to go to the hospital. At the hospital his liver function tests were elevated and he was diagnosed with Serum sickness. He states that no one knows how to treat it. He is still in extreme pain.
Age: 37.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Blood pressure fluctuation, Fatigue, Liver function test abnormal, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of serum sickness in a 37-year-old male patient who received TWINRIX (batch number 3NK9A, expiry date 27th May 2017). On an unknown date, the patient received TWINRIX. On an unknown date, 2 days after receiving TWINRIX, the patient experienced serum sickness (serious criteria hospitalization), pain in arm (serious criteria hospitalization), shoulder pain (serious criteria hospitalization), pain in hip (serious criteria hospitalization), fatigue (serious criteria hospitalization) and change in blood pressure (serious criteria hospitalization). On an unknown date, the outcome of the serum sickness, pain in arm, shoulder pain, pain in hip, fatigue and change in blood pressure were not recovered/not resolved. The reporter considered the serum sickness, pain in arm, shoulder pain, pain in hip, fatigue and change in blood pressure to be related to TWINRIX. Additional information received: Reporter states that he received the TWINRIX vaccine on March 28, 2015 at his place of work by a nurse. Two days after receiving the vaccine he had shooting pain in both arms, shoulders, and hips. Within a week he was feeling fatigue and "could feel his heart beating throughout his body". He contacted his physician and was told to go to the hospital. At the hospital his liver function tests were elevated and he was diagnosed with Serum sickness. He states that no one knows how to treat it. He is still in extreme pain.
Age: 37.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Pain, Pain in extremity, Serum sickness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of serum sickness in a 37-year-old male patient who received TWINRIX (batch number 3NK9A, expiry date 27th May 2017). On an unknown date, the patient received TWINRIX. On an unknown date, 2 days after receiving TWINRIX, the patient experienced serum sickness (serious criteria hospitalization), pain in arm (serious criteria hospitalization), shoulder pain (serious criteria hospitalization), pain in hip (serious criteria hospitalization), fatigue (serious criteria hospitalization) and change in blood pressure (serious criteria hospitalization). On an unknown date, the outcome of the serum sickness, pain in arm, shoulder pain, pain in hip, fatigue and change in blood pressure were not recovered/not resolved. The reporter considered the serum sickness, pain in arm, shoulder pain, pain in hip, fatigue and change in blood pressure to be related to TWINRIX. Additional information received: Reporter states that he received the TWINRIX vaccine on March 28, 2015 at his place of work by a nurse. Two days after receiving the vaccine he had shooting pain in both arms, shoulders, and hips. Within a week he was feeling fatigue and "could feel his heart beating throughout his body". He contacted his physician and was told to go to the hospital. At the hospital his liver function tests were elevated and he was diagnosed with Serum sickness. He states that no one knows how to treat it. He is still in extreme pain.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Fall, Head injury, Hyperhidrosis
Clinical narrative: Nausea, vomiting, sweating, fainting, chills, extreme pain in arm that she got vaccine, fall.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Nausea, Neck pain, X-ray limb normal
Clinical narrative: Nausea, vomiting, sweating, fainting, chills, extreme pain in arm that she got vaccine, fall.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood lactic acid, Blood magnesium, Chills, Computerised tomogram head, Differential white blood cell count
Clinical narrative: Nausea, vomiting, sweating, fainting, chills, extreme pain in arm that she got vaccine, fall.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Electrocardiogram, Fall, Full blood count, Hyperhidrosis, Metabolic function test
Clinical narrative: Nausea, vomiting, sweating, fainting, chills, extreme pain in arm that she got vaccine, fall.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Nausea, Pain in extremity, Syncope, Troponin, Vomiting
Clinical narrative: Nausea, vomiting, sweating, fainting, chills, extreme pain in arm that she got vaccine, fall.
Age: 77.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: X-ray limb
Clinical narrative: Nausea, vomiting, sweating, fainting, chills, extreme pain in arm that she got vaccine, fall.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Migraine, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 15-year-old male patient who received HAVRIX 1440. On 11th August 2014 13:00, the patient received the 1st dose of HAVRIX 1440 (intramuscular) 1 ml. In 2014, an unknown time after receiving HAVRIX 1440, the patient experienced fever and migraine headache. On 11th August 2014, the patient experienced accidental overdose. On an unknown date, the outcome of the fever and migraine headache were not recovered/not resolved and the outcome of the accidental overdose was unknown. The reporter considered the fever and migraine headache to be unlikely related to HAVRIX 1440. Additional information provided: This pharmacy inadvertently administered an adult dose to this 14 year old patient. The patient's father recently inquired if the patient's high fevers and migraine headaches could be caused by this maladministration. He could not state specifically when these events began but stated that they had been occurring intermittently over the past year.
Age: 14.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, Migraine, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 15-year-old male patient who received HAVRIX 1440. On 11th August 2014 13:00, the patient received the 1st dose of HAVRIX 1440 (intramuscular) 1 ml. In 2014, an unknown time after receiving HAVRIX 1440, the patient experienced fever and migraine headache. On 11th August 2014, the patient experienced accidental overdose. On an unknown date, the outcome of the fever and migraine headache were not recovered/not resolved and the outcome of the accidental overdose was unknown. The reporter considered the fever and migraine headache to be unlikely related to HAVRIX 1440. Additional information provided: This pharmacy inadvertently administered an adult dose to this 14 year old patient. The patient's father recently inquired if the patient's high fevers and migraine headaches could be caused by this maladministration. He could not state specifically when these events began but stated that they had been occurring intermittently over the past year.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC
Symptoms: Abnormal behaviour, Brain oedema, Depressed level of consciousness, Laboratory test, Lethargy
Clinical narrative: Changes in behavior and alertness, lethargic.  Brain swelled, screaming if anything touched the head/skull. Severe symptoms lasted for 2 days.  Lymph nodes erupted across the entire back of the head and neck and remained large for months.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC
Symptoms: Lymphadenopathy, Screaming, Tenderness
Clinical narrative: Changes in behavior and alertness, lethargic.  Brain swelled, screaming if anything touched the head/skull. Severe symptoms lasted for 2 days.  Lymph nodes erupted across the entire back of the head and neck and remained large for months.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Erythema multiforme. NO Steven's Johnsons. No other symptoms.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection Site Reaction - redness, swelling, erythema.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 51 year old female patient. The patient's medical history included hysterectomy prior to taking ZOSTAVAX. Drug reactions/allergies: none. On 23-MAY-2015 the patient was vaccinated with ZOSTAVAX (route, dose, frequency and lot # unspecified by reporter). Physician reported that patient experienced redness at the injection area on 24-MAY-2015. Physician reported patient had 10-15 vesicles around the injection site on 26-MAY-2015 described as blisters with clear fluid inside. No treatment given for the events but the patient saw the physician. Lab diagnostics studies were not performed. VZV packet faxed. No additional information to report. The outcome of vaccination site vesicles and vaccination site erythema was reported as not resolved. Causality assessment was not reported. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about concomitant medications, pertinent medical history and drug reactions was provided. On unknown dates, an unspecified number of patients had been subcutaneously administered improperly stored (since 22-APR-2015) doses of PROQUAD (Merck) (dose, frequency, route of administration not reported), (lot # K020747, expiration date 30-APR-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health care professional refers to a 17 year old male patient. On 10-FEB-2015 the patient was vaccinated with (Oka-Merck) PROQUAD injection (lot # K020753; expiry: 30-APR-2016) (dose, frequency and route unspecified). Concomitant medications were not provided. Nurse stated that the patient received their first dose of MMR II and (Oka/Merck) VARIVAX on 12-JUN-1998. The patient received their second dose of (Oka/Merck) VARIVAX on 12-JUN-1998. The patient received their second dose of MMR II, live on 30-JAN-2002 and their second dose of VARIVAX (Oka/Merck) on 01-AUG-2014. On 10-FEB-2015 the patient was inadvertently administered a PROQUAD (Oka-Merck). No adverse effects reported. No further information provided. Outcome of wrong drug administered was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING OF INJECTION SITE. 4 INCHES WIDE BY 3 INCHES LONG. HOT AND HARD TO THE TOUCH.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Flushing, Injection site erythema, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, warmth, edema, and itching at injection site on L deltoid. Facial flushing, nausea, and pain radiating down L arm.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Nausea, Pain in extremity
Clinical narrative: Swelling, redness, warmth, edema, and itching at injection site on L deltoid. Facial flushing, nausea, and pain radiating down L arm.
Age: 0.85
Sex: M
Vaccine: DPP, DTAPH, IPV, PPV, TD
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Discomfort, Oropharyngeal pain
Clinical narrative: Fever, sever upset stomach, diarrhea, running nose, sore throat, lack of appetite, over all discomfort.
Age: 0.85
Sex: M
Vaccine: DPP, DTAPH, IPV, PPV, TD
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever, sever upset stomach, diarrhea, running nose, sore throat, lack of appetite, over all discomfort.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Abnormal behaviour, Anxiety, Dyskinesia, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: A consumer report has been received. The report concerns a 2 year old male consumer, height: 39.0 inches; weight: 32.0 pounds. No medical history and no concomitant medication were provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2014. It was reported that patient started having seizure like activity, MRIs and EEG all came back normal. She reported however that it had progressed more into behavioral problems that include hand movements, staring spells, ticks, extreme activity and extreme anxiety. She reported that his behavioral issues were more than a toddler, he had vocal and motor ticks all after the FLUMIST. She believed that the medication may have triggered this reaction in him. She stated her son was put on Oxcarbazepine 9 ml per day for seizures but now is being weaned off the medication and currently on 2 ml daily. She reported that was no longer classified as seizures but diagnosed as abnormal behavioral episodes, stereotypy. She reported he also had seasonal allergies now. The outcome of the event of seizure like activity, staring spells, abnormal behavioral episodes-stereotypy, seasonal allergies, motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety was unknown. The Az physician upgraded the event seizure like activity, staring spells and abnormal behavioral episodes, stereotypy to serious due to important medical event. The Az physician identified the events motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety from the narrative of the source document and assessed them to be non-serious. The reporter assessed the event seasonal allergies to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Psychomotor hyperactivity, Seasonal allergy, Seizure like phenomena, Staring, Stereotypy
Clinical narrative: A consumer report has been received. The report concerns a 2 year old male consumer, height: 39.0 inches; weight: 32.0 pounds. No medical history and no concomitant medication were provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2014. It was reported that patient started having seizure like activity, MRIs and EEG all came back normal. She reported however that it had progressed more into behavioral problems that include hand movements, staring spells, ticks, extreme activity and extreme anxiety. She reported that his behavioral issues were more than a toddler, he had vocal and motor ticks all after the FLUMIST. She believed that the medication may have triggered this reaction in him. She stated her son was put on Oxcarbazepine 9 ml per day for seizures but now is being weaned off the medication and currently on 2 ml daily. She reported that was no longer classified as seizures but diagnosed as abnormal behavioral episodes, stereotypy. She reported he also had seasonal allergies now. The outcome of the event of seizure like activity, staring spells, abnormal behavioral episodes-stereotypy, seasonal allergies, motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety was unknown. The Az physician upgraded the event seizure like activity, staring spells and abnormal behavioral episodes, stereotypy to serious due to important medical event. The Az physician identified the events motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety from the narrative of the source document and assessed them to be non-serious. The reporter assessed the event seasonal allergies to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Tic
Clinical narrative: A consumer report has been received. The report concerns a 2 year old male consumer, height: 39.0 inches; weight: 32.0 pounds. No medical history and no concomitant medication were provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2014. It was reported that patient started having seizure like activity, MRIs and EEG all came back normal. She reported however that it had progressed more into behavioral problems that include hand movements, staring spells, ticks, extreme activity and extreme anxiety. She reported that his behavioral issues were more than a toddler, he had vocal and motor ticks all after the FLUMIST. She believed that the medication may have triggered this reaction in him. She stated her son was put on Oxcarbazepine 9 ml per day for seizures but now is being weaned off the medication and currently on 2 ml daily. She reported that was no longer classified as seizures but diagnosed as abnormal behavioral episodes, stereotypy. She reported he also had seasonal allergies now. The outcome of the event of seizure like activity, staring spells, abnormal behavioral episodes-stereotypy, seasonal allergies, motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety was unknown. The Az physician upgraded the event seizure like activity, staring spells and abnormal behavioral episodes, stereotypy to serious due to important medical event. The Az physician identified the events motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety from the narrative of the source document and assessed them to be non-serious. The reporter assessed the event seasonal allergies to be non-serious.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Pyrexia, Sepsis
Clinical narrative: After 4mo vaccines pt presented 6/8/15 with diarrhea and fever. Admitted to hospital for dehydration/sepsis. Vaccine administered 5/29/15.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. In April 2015, the patient was vaccinated with unspecified dose of ZOSTAVAX (lot#, expiration date and route of administration were not reported) and then received another dose on 19-JUN-2015 (0.65 ml, subcutaneously; lot#, expiration date and anatomical location were not reported). The patient did not experience any adverse events. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours after kindergarten shots given, patient returned to our office with left arm red/hot/swollen x 2 in x 2 in.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site pain, Musculoskeletal stiffness, Nausea, Pyrexia
Clinical narrative: PATIENT WOKE UP THE DAY AFTER RECIEVING VACCINES WITH A SEVERE HEADACHE, STIFFNESS, FEVER, AND SWOLLEN FACE. COMPLAINS THAT HEADACHE WAS RELENTLESS AND NOTHING WAS HELPING INCLUDING OTC MEDS. MOM STATED HE FELT SOME NAUSEA DUE TO HEADACHE AND ARM AT INJECTION SITE WAS VERY SORE. NO REDNESS OR WARMTH TO INJECTION SITE NOTED. HEADACHE PERSISTED THROUGH SUNDAY AFTERNOON.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: PATIENT WOKE UP THE DAY AFTER RECIEVING VACCINES WITH A SEVERE HEADACHE, STIFFNESS, FEVER, AND SWOLLEN FACE. COMPLAINS THAT HEADACHE WAS RELENTLESS AND NOTHING WAS HELPING INCLUDING OTC MEDS. MOM STATED HE FELT SOME NAUSEA DUE TO HEADACHE AND ARM AT INJECTION SITE WAS VERY SORE. NO REDNESS OR WARMTH TO INJECTION SITE NOTED. HEADACHE PERSISTED THROUGH SUNDAY AFTERNOON.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Reports localized swelling and pain at insertion site. Patient has to move arm slowly.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Culture stool negative, Diarrhoea, Rash, Skin disorder
Clinical narrative: Patient started with diarrhea and skin breakdown around buttock area.  Patient is still having these issues.  Mupirocin ointment prescribed for skin breakdown and rash.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Complex regional pain syndrome, Injection site pain, Joint range of motion decreased, Pain in extremity, Periarthritis
Clinical narrative: When injected there was an incredible amount of pain. (was told the syringe was not working) The pain continued, and there was a huge loss of range of motion. Pain has continued to increase down my arm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: When injected there was an incredible amount of pain. (was told the syringe was not working) The pain continued, and there was a huge loss of range of motion. Pain has continued to increase down my arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Significant hyperemia, color, tenderness of upper extremity also with associated bruising.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Feeling hot, Pain in extremity, Product colour issue
Clinical narrative: Initial unsolicited report received from a consumer (patient parent) on 17 June 2015. A 61-year-old female patient had received first dose of ADACEL (batch number: U4870BA, expiry date: 10 March 2016, dose, route of administration were not reported) in left deltoid on 08 June 2015. Illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions reported as none. Concomitant medications were not reported. On 11 June 2015, three days after vaccination, the patient developed painful left arm with redness and heat. On 13 June 2015, the arm began weeping and the redness went more than half way down her arm. The patient went to an urgent care and was diagnosed with cellulitis. Also, the patient was worried as the product she received was orange in color. It's a product color issue. Patient required ER/doctor visit. Relevant diagnostic tests/laboratory data reported as none. Corrective treatment included application of ice, antibiotics. At the time of this report, the patient was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event: cellulitis, painful left arm with redness and heat, painful left arm with redness and heat/the arm began weeping and the redness went more than 1/2 way down her arm and the product she received was orange. Documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Secretion discharge
Clinical narrative: Initial unsolicited report received from a consumer (patient parent) on 17 June 2015. A 61-year-old female patient had received first dose of ADACEL (batch number: U4870BA, expiry date: 10 March 2016, dose, route of administration were not reported) in left deltoid on 08 June 2015. Illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions reported as none. Concomitant medications were not reported. On 11 June 2015, three days after vaccination, the patient developed painful left arm with redness and heat. On 13 June 2015, the arm began weeping and the redness went more than half way down her arm. The patient went to an urgent care and was diagnosed with cellulitis. Also, the patient was worried as the product she received was orange in color. It's a product color issue. Patient required ER/doctor visit. Relevant diagnostic tests/laboratory data reported as none. Corrective treatment included application of ice, antibiotics. At the time of this report, the patient was not recovered from the events. Upon medical review, the case was considered as serious due to important medical event: cellulitis, painful left arm with redness and heat, painful left arm with redness and heat/the arm began weeping and the redness went more than 1/2 way down her arm and the product she received was orange. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Palpitations
Clinical narrative: Four days after receiving the vaccine, I started experiencing severe heart palpitations. I was hospitalized for observation overnight. No med changes made. The palpitations lasted for 3 weeks then diminished. I have had a few "thumps" in the previous 10 years. Taking atenolol for that.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Aphasia, Feeling abnormal, Feeling hot, Heart rate increased, Pain in extremity
Clinical narrative: By 11:00 PM of the day I received the vaccine, following rapid heartbeats and feeling like painful gas was moving up and down my arms, I fell into a deep sleep. I saw myself shot from a cannon, I floated away from a light then suddenly I was shot back to the light, and started feeling extremely hot. I lay on bathroom floor until about 4:30 AM. I couldn't talk. My wife wanted to call 911 but I motioned "no". By 8:00 AM my wife called the doctor but the call was not returned. I called the next day.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain, Dyspnoea, Erythema, Hypersensitivity, Palpitations
Clinical narrative: I had cut my hand a week ago, and noticed it wasn't getting any better so after church I went to the emergency room. Because I'm Diabetic and it wasn't healing, so they gave me a tetanus shot. And pain shot , antibiotic shot. I go home and two hours later, my throat was closing I couldn't breathe, heart racing my arm was red. Itching.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Throat tightness
Clinical narrative: I had cut my hand a week ago, and noticed it wasn't getting any better so after church I went to the emergency room. Because I'm Diabetic and it wasn't healing, so they gave me a tetanus shot. And pain shot , antibiotic shot. I go home and two hours later, my throat was closing I couldn't breathe, heart racing my arm was red. Itching.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Patient was adminsitered vaccine at 230pm on 6/19, and stated reaction started that evening around 6pm. Patient had her arm and leg on ONLY the left side of her body swell up. Patient followed up with the physician on Monday 6/22, by which time the swelling had almost completely gone away.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pharyngeal disorder, Pyrexia, Rash generalised, Rhinitis
Clinical narrative: Coryza, followed by sore throat, spots on throat, fever, then rash on body.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: DIZZINESS, LIGHT HEADED, ROOM SPINNING.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Back pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient had 4 doses of Imovax. Symptoms Low back pain, Leg stiffness(could not use legs).
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Patient received Prevnar 13 vaccine on 6/18/15 and reported back to clinicin on 6/23/15 with itching and urticaria around injection site of 2cm x4cm. Patient given corticosteriod cream.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Culture negative, Injection site rash, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: T.C. received from employee health.  She reported the patient who is an employee, had a varicella vaccine on 06/11/2015 @ County Health Clinic.  On 06/15/2015, patient experienced fever, sore throat and rash to legs, torso and upper arms, a lacy rash in appearence.  Patient went to an ED on 06/16/2015 amd was given prednisone. Per health department, patient's symptoms have since subsided. Also, per health department, ED doctor told patient that she most likely had an adverse reaction to the varicella vaccine and she should not receive another vaccine.  06/23/2015-T.C. to Pt to follow up.  Patient stated that her rash is gone-states she has some nasal congestion and sore throat in am- no fever.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Streptococcus test negative, Vaccination complication
Clinical narrative: T.C. received from employee health.  She reported the patient who is an employee, had a varicella vaccine on 06/11/2015 @ County Health Clinic.  On 06/15/2015, patient experienced fever, sore throat and rash to legs, torso and upper arms, a lacy rash in appearence.  Patient went to an ED on 06/16/2015 amd was given prednisone. Per health department, patient's symptoms have since subsided. Also, per health department, ED doctor told patient that she most likely had an adverse reaction to the varicella vaccine and she should not receive another vaccine.  06/23/2015-T.C. to Pt to follow up.  Patient stated that her rash is gone-states she has some nasal congestion and sore throat in am- no fever.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity, Rash generalised, Urticaria
Clinical narrative: My daughter aged 14, went to the doctor on Tuesday for allergies. While there the doctor gave her the 2nd shot to the 3 shot series of GARDASIL. The following day she broke out all over her body in a terrible rash. She complained of her feet hurting and the joints in her hands. I had given her BENADRYL to help. The next day once again she woke up even worse than the first, the hives had spread.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, C-reactive protein increased, Gait disturbance, Mobility decreased, Musculoskeletal pain
Clinical narrative: Had a ZOSTAVAX vaccination 2/11/15. Around a week later began experiencing very painful left jaw pain, stiffened neck muscles, painful wrists, and hip girdle pain. This progressed to both jaws, neck, shoulders, forearms, wrists, hips, glutes, and thighs. Difficult to walk and general loss of functionality. In May I was diagnosed with Polymyalgia Rheumatica. Per the Merck pharma site PMR is potential rare serious side effect.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pain in jaw, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Had a ZOSTAVAX vaccination 2/11/15. Around a week later began experiencing very painful left jaw pain, stiffened neck muscles, painful wrists, and hip girdle pain. This progressed to both jaws, neck, shoulders, forearms, wrists, hips, glutes, and thighs. Difficult to walk and general loss of functionality. In May I was diagnosed with Polymyalgia Rheumatica. Per the Merck pharma site PMR is potential rare serious side effect.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Arthritis, Blood chloride abnormal, Blood creatinine abnormal, Double stranded DNA antibody
Clinical narrative: My daughter had a single injection of GARDASIL on 2/16/15. Within one month she developed severe arthritis and had increased ANA, inflammatory blood readings, etc. She was RA negative. She started having issues walking and with mobility. She had a migraine. She was hospitalized for 4 days in late March and was diagnosed with SLE. Her kidney function became impaired but is now somewhat improved.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Glomerular filtration rate, Inflammation, Inflammatory marker test, Migraine
Clinical narrative: My daughter had a single injection of GARDASIL on 2/16/15. Within one month she developed severe arthritis and had increased ANA, inflammatory blood readings, etc. She was RA negative. She started having issues walking and with mobility. She had a migraine. She was hospitalized for 4 days in late March and was diagnosed with SLE. Her kidney function became impaired but is now somewhat improved.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Renal impairment, Systemic lupus erythematosus
Clinical narrative: My daughter had a single injection of GARDASIL on 2/16/15. Within one month she developed severe arthritis and had increased ANA, inflammatory blood readings, etc. She was RA negative. She started having issues walking and with mobility. She had a migraine. She was hospitalized for 4 days in late March and was diagnosed with SLE. Her kidney function became impaired but is now somewhat improved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received 3 shots on Friday 6-19-15. DAPTACEL, IPOL, PROQUAD. Mom noticed pt leg was swollen to a softball size knot in her left leg which was hot to touch. Mom called me on 6-22-15 which I made her an appointment to have Dr. look at it.
Age: 0.49
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave a rotavirus vaccine to a 5 mth old with no hx of receiving of rotavirus. Child exceeded age limit for first time dose under rotavirus catch-up vaccine schedule.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: On 5/29/15, pt called office reporting extreme pain in the shoulder upper at the site of her PNEUMOVAX injection administered the day before. She had decreased ROM secondary to pain which she described as an ache at 10/10. She denied redness or heat, but did describe some slight swelling at the site. She had already applied heat and was encouraged to apply cool compresses and take OTC analgesic. She was offered an appointment for further assessment and opted to see how she progressed over the course of the next several days, but did say she would go to Urgent Care or Emergency Room for worsening S and S. Follow up call after weekend indicated the pt was having some relief and getting better with pain and decreased ROM.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Joint range of motion decreased, Localised oedema, Musculoskeletal pain, Pain
Clinical narrative: On 5/29/15, pt called office reporting extreme pain in the shoulder upper at the site of her PNEUMOVAX injection administered the day before. She had decreased ROM secondary to pain which she described as an ache at 10/10. She denied redness or heat, but did describe some slight swelling at the site. She had already applied heat and was encouraged to apply cool compresses and take OTC analgesic. She was offered an appointment for further assessment and opted to see how she progressed over the course of the next several days, but did say she would go to Urgent Care or Emergency Room for worsening S and S. Follow up call after weekend indicated the pt was having some relief and getting better with pain and decreased ROM.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Muscular weakness, Pyrexia
Clinical narrative: Pt also reported redness and swelling at injection site same day following vaccine pt started feeling weakness in arms and legs. Reports fever for 1 day sx lasted through weekend and started resolving on 6-22-15. Pt reported complete resolution 6-23-15.
Age: 0.44
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Administered Kinrix instead of Pedvax.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Epistaxis, Face injury, Gingival bleeding, Gingival swelling, Lip injury
Clinical narrative: Shortly after receiving vaccines- pt walked to front of office and fainted-landing directly on face.  He briefly lost consciousness, and had clonic tonic posturing according to dad. This lasted a few seconds and then he was awake and alert.  He had bleeding from nose and mouth. He was able to walk back to exam room. HR 99  Pulse ox 97%. Ice packs were applied to nose and mouth. PE: alert and oreinted x 3. Nose- fresh blood in both nares and swelling of nasal bridge -tender to palp. Abrasion on nose and under left nares. Mouth- 4 upper incisors with swelling and bleeding around gums and appear displaced. Laceration with oozing on lower lip.. Pt was monitored for 40 minutes.  Dad also felt lightheaded and we had him lay down and drink water. Bleeding and oozing stopped.  Pt was able to walk. Denies headache, dizziness, nausea or double vision. Denies head injury. Plan- pt will go to ED for further eval and will likely need a dentist. Dad was instructed to take pt to ED immediately for further EVAL. On discharge --90/56  HR 72.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Mouth haemorrhage, Nasal congestion, Skin abrasion, Syncope
Clinical narrative: Shortly after receiving vaccines- pt walked to front of office and fainted-landing directly on face.  He briefly lost consciousness, and had clonic tonic posturing according to dad. This lasted a few seconds and then he was awake and alert.  He had bleeding from nose and mouth. He was able to walk back to exam room. HR 99  Pulse ox 97%. Ice packs were applied to nose and mouth. PE: alert and oreinted x 3. Nose- fresh blood in both nares and swelling of nasal bridge -tender to palp. Abrasion on nose and under left nares. Mouth- 4 upper incisors with swelling and bleeding around gums and appear displaced. Laceration with oozing on lower lip.. Pt was monitored for 40 minutes.  Dad also felt lightheaded and we had him lay down and drink water. Bleeding and oozing stopped.  Pt was able to walk. Denies headache, dizziness, nausea or double vision. Denies head injury. Plan- pt will go to ED for further eval and will likely need a dentist. Dad was instructed to take pt to ED immediately for further EVAL. On discharge --90/56  HR 72.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tenderness, Tonic clonic movements, Wound secretion
Clinical narrative: Shortly after receiving vaccines- pt walked to front of office and fainted-landing directly on face.  He briefly lost consciousness, and had clonic tonic posturing according to dad. This lasted a few seconds and then he was awake and alert.  He had bleeding from nose and mouth. He was able to walk back to exam room. HR 99  Pulse ox 97%. Ice packs were applied to nose and mouth. PE: alert and oreinted x 3. Nose- fresh blood in both nares and swelling of nasal bridge -tender to palp. Abrasion on nose and under left nares. Mouth- 4 upper incisors with swelling and bleeding around gums and appear displaced. Laceration with oozing on lower lip.. Pt was monitored for 40 minutes.  Dad also felt lightheaded and we had him lay down and drink water. Bleeding and oozing stopped.  Pt was able to walk. Denies headache, dizziness, nausea or double vision. Denies head injury. Plan- pt will go to ED for further eval and will likely need a dentist. Dad was instructed to take pt to ED immediately for further EVAL. On discharge --90/56  HR 72.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: The arm administered in is red, warm and swollen. Cellulitis/MD treated with hydrocortisone and NEOSPORIN, f/u with cephalexin and prednisone.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: Large red area 5 days after getting the vaccine. There is still a pale pink area, which still hurts.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Joint range of motion decreased, Rash erythematous, Rash macular
Clinical narrative: Evening after injection, pt developed severe 8/10 (L) deltoid pain, decreased ROM. This lasted for 4days. On the 5th day he developed a red confluent macular rash in block pattern distal to injection site approx 20 x 5 cm.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test positive, Anaphylactic shock, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program refers to a female patient in her late 70's. There were no medical history, concurrent conditions and concomitant therapies. On an unknown date in the Spring 2009, the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route of administration not reported) at pharmacy. The patient developed immediate severe allergic reaction. She was taken to the emergency room (ER), where she received epinephrine. She recovered within hours from the onset of the adverse event (in the Spring 2009) and was never admitted to the hospital. Diagnostic tests assessing the patient's sensitivity to a variety of agents were performed subsequently by allergist in 2009 and demonstrated that the patient had severe allergy to gelatin. The reporter considered anaphylactic shock to be related to ZOSTAVAX and immediately life-threatening. Upon internal review anaphylactic shock was considered to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Flu like symptoms-fever-chills-body aches. Red and warm at injection site, warm to touch, painful. TX: MEDROL dose pack and SEPTRA DS 1 BID x 10 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms-fever-chills-body aches. Red and warm at injection site, warm to touch, painful. TX: MEDROL dose pack and SEPTRA DS 1 BID x 10 days.
Age: 16.0
Sex: M
Vaccine: HIBV, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events, this is to report a medication error. Patient was to receive MENACTRA vaccine and was given PEDVAXHIB in error. No adverse reaction reported.
Age: 18.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events, this is to report a medication error. Patient was to receive MENACTRA vaccine and was given PEDVAXHIB in error. No adverse reaction reported.
Age: 26.0
Sex: F
Vaccine: HIBV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events, this is to report a medication error. Patient was to receive MENACTRA vaccine and was given PEDVAXHIB in error. No adverse reaction reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Contraindication to vaccination, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old female patient who received KINRIX (batch number NS74P, expiry date 20th March 2017). Previously administered products included MMR II. Concurrent medical conditions included nausea. Concomitant products included Hepatitis B. On 8th June 2015, the patient received KINRIX. On 8th June 2015, less than a day after receiving KINRIX, the patient experienced contraindication to vaccination. On 9th June 2015, the patient experienced injection site swelling and injection site erythema. On 10th June 2015, the patient experienced extensive swelling of vaccinated limb, large arm swelling and blister. The patient was treated with dermatologists nos (Topical agent). On an unknown date, the outcome of the extensive swelling of vaccinated limb, large arm swelling, injection site swelling, injection site erythema and blister were not recovered/not resolved and the outcome of the contraindication to vaccination was unknown. The reporter considered the extensive swelling of vaccinated limb, large arm swelling, injection site swelling, injection site erythema and blister to be almost certainly related to KINRIX. Additional information received: Patient received KINRIX for her 5th DTaP series and her 3rd IPV series. There was no puff from the needle point so no sign of an infection. The big clear blisters were about an inch in size located less than 1/2-inch below the injection site. Her arm (entire bicep down to the elbow) was really big and swollen. The patient was prescribed AUGMENTIN but she has currently only been treated with topicals. If the patient is not better by tomorrow then AUGMENTIN will be started.