chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 04-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter.  Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 05-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 07-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M024683 with expiry date on 18-MAY-2016; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient called the evening after Pneumonia shot given to report arm soreness to the pharmacist on duty.  She later called back to report numbness and went to the ER to be evaluated.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left arm swollen, hot, red, sore to touch, denies fever.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea exertional
Clinical narrative: Generalized weakness and SOB on exertion.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Eyelid oedema, Vision blurred
Clinical narrative: Eyelid swelling, blurred vision.
Age: 10.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Skin rash with pain, diagnosed with shingles.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Skin of upper Left arm swollen and red and arm sore.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Amnesia, Autonomic nervous system imbalance, Biopsy skin abnormal, Dizziness, Dyspnoea
Clinical narrative: Gradual dysautonomia symptom complex developed in 2008 after receiving 8 vaccines, also sustained electric shock episode. Now diagnosed with small fiber neuropathy and is undergoing medical separation from employment. Vaccination history 2008: 10 Feb: Typhoid vl, Hepatitis B #1, Anthrax #3; 1 Mar: Anthrax #4; 5 Apr: Varicella, Hepatitis B #2; 29 Aug: Anthrax #5; 9 Sept: Intranasal Influenza; 5 Oct: Hepatitis B #3. Symptoms: Dizziness and giddiness, Disturbance of skin sensation, Palpitations, Shortness of breath, Symptom, nervous/musculoskeletal NEC, Symptom, memory loss, Malaise and fatigue.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Fatigue, Malaise, Musculoskeletal disorder, Nervous system disorder, Palpitations
Clinical narrative: Gradual dysautonomia symptom complex developed in 2008 after receiving 8 vaccines, also sustained electric shock episode. Now diagnosed with small fiber neuropathy and is undergoing medical separation from employment. Vaccination history 2008: 10 Feb: Typhoid vl, Hepatitis B #1, Anthrax #3; 1 Mar: Anthrax #4; 5 Apr: Varicella, Hepatitis B #2; 29 Aug: Anthrax #5; 9 Sept: Intranasal Influenza; 5 Oct: Hepatitis B #3. Symptoms: Dizziness and giddiness, Disturbance of skin sensation, Palpitations, Shortness of breath, Symptom, nervous/musculoskeletal NEC, Symptom, memory loss, Malaise and fatigue.
Age: 45.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Paraesthesia, Small fibre neuropathy, Tilt table test positive
Clinical narrative: Gradual dysautonomia symptom complex developed in 2008 after receiving 8 vaccines, also sustained electric shock episode. Now diagnosed with small fiber neuropathy and is undergoing medical separation from employment. Vaccination history 2008: 10 Feb: Typhoid vl, Hepatitis B #1, Anthrax #3; 1 Mar: Anthrax #4; 5 Apr: Varicella, Hepatitis B #2; 29 Aug: Anthrax #5; 9 Sept: Intranasal Influenza; 5 Oct: Hepatitis B #3. Symptoms: Dizziness and giddiness, Disturbance of skin sensation, Palpitations, Shortness of breath, Symptom, nervous/musculoskeletal NEC, Symptom, memory loss, Malaise and fatigue.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Immediate post-injection reaction, Pain, Paraesthesia, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous report was received from a 66 year old male patient. with no drug reactions or allergies, who was reporting on himself. The patient had no pertinent medical history. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 time immunization (dose, lot # and expiration date were not provided) for shingles prevention. On the same day, the patient received a dose of PNEUMOVAX23 (reported as "pneumonia vaccine (unspecified)"; dose, route, lot # and expiration date were not provided). Concomitant therapies included lisinopril (unknown manufacturer) and atorvastatin. On 01-DEC-2016 (reported as "immediately afterwards"), the patient experienced swelling and puffiness in his left armpit, accompanied by a slight fever. As time progressed, the feeling became very painful, like "pins and needles", and he began to notice red dots as well. The patient sought medical attention and received an unspecified treatment for the events. The outcome of the events was unknown at the time of the report. The relatedness between the events and suspect vaccines was not reported. Additional information is not expected, as there was no consent to contact the patient's physician.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a 66 year old male patient. with no drug reactions or allergies, who was reporting on himself. The patient had no pertinent medical history. On 01-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 time immunization (dose, lot # and expiration date were not provided) for shingles prevention. On the same day, the patient received a dose of PNEUMOVAX23 (reported as "pneumonia vaccine (unspecified)"; dose, route, lot # and expiration date were not provided). Concomitant therapies included lisinopril (unknown manufacturer) and atorvastatin. On 01-DEC-2016 (reported as "immediately afterwards"), the patient experienced swelling and puffiness in his left armpit, accompanied by a slight fever. As time progressed, the feeling became very painful, like "pins and needles", and he began to notice red dots as well. The patient sought medical attention and received an unspecified treatment for the events. The outcome of the events was unknown at the time of the report. The relatedness between the events and suspect vaccines was not reported. Additional information is not expected, as there was no consent to contact the patient's physician.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On 18-NOV-2016, the patient was vaccinated with the first dose of VARIVAX,  lot # M031969, expiration date 30-JUN-2018, 0.5 ml administered per subcutaneous route for prophylaxis. On 12-DEC-2016, the patient received the second dose of VARIVAX, lot # M031969, expiration date 30-JUN-2018, 0.5 ml administered per subcutaneous route for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 0.92
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 14-NOV-2016, approximately days before the first birthday, the patient was vaccinated with M-M-R II (lot # reported as M022407 with expiry date on 02-MAY-2018; dose and route of administration were not reported) and with VARIVAX (lot # M030138 with expiry date on 15-JUN-2018; dose and route of administration were not reported). On 19-DEC-2016, the patient came into the office due to a fever. The outcome of fever was unknown. The relatedness between the event of fever and the M-M-R II and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 29-DEC-2016, the patient was vaccinated with M-M-R II lot # K010318 (strength, dosage and route unspecified) for prophylaxis, which was with the expiration date of 22-JUL-2016. No adverse effects reported. No product quality complaint was involved. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine, Drug administered to patient of inappropriate age
Clinical narrative: A spontaneous report received from a health professional via Pfizer concerning a patient of unknown gender. The patient was allergic to codeine, BACTRIM, TRAVATAN, LUMIGAN, statin and DEPO-MEDROL. Patient's concomitant medications included pregabalin, methylprednisolone acetate, diclofenac, misoprostol, lactobacillus reuteri, diltiazem hydrochloride, theophylline, dexlansoprazole, furosemide, valacyclovir hydrochloride, nicotinic acid, magnesium, calcium, cholecalciferol, biotin, fish oil, acetylsalicylic acid, vitamins nos, xantofyl, chondroitin sulfate, glucosamine, hypromellose, tears, prednisone, ipratropium bromide, salbutamol, levofloxacin and ketotifen. On an unspecified date, patient received Influenza Virus Vaccine Live (Intranasal). It was reported that patient had live flu vaccine allergy (Preferred Term: Allergy to vaccine). Vaccine used in patient (age more than 59 years) (Preferred Term: drug administered to patient of inappropriate age) considered as an off label use (Preferred Term: off label use). The outcome for Live flu vaccine allergy, inappropriate age at vaccine administration and off label use was unknown. The report was considered to be non-serious by company physician. The events of off label use and inappropriate age at vaccine administration was identified by company physician from source narrative and assessed to be non serious. Corrected Report 19-Sep-2016: New event added as off label use and inappropriate age at vaccine administration. Narrative updated.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Influenza, Influenza A virus test positive, Pyrexia, Vomiting
Clinical narrative: A report has been received from a health professional (nurse practitioner), who was also the mother of the patient via a medical representative, concerning a 15 year old male patient. Relevant medical history, concurrent disease and concomitant medication were not reported. On 08-Oct-2014, the mother administered FluMist Quadrivalent (influenza virus vaccine live, intranasal) 0.2 millilitres vaccine by nasal as a onetime dose for flu to her son. On 13-Dec-2014, the patient caught the flu, experienced fever, headache and a positive result for Influenza A. The patient also vomited, after received Tamiflu as a treatment. The outcome of the event of caught flu, fever, vomited, positive test for influenza A and headache was unknown. The report was considered to be non-serious by the company physician.
Sex: F
Vaccine: FLUN3
Symptoms: Circumstance or information capable of leading to medication error, Nasopharyngitis, Rhinorrhoea
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient (height: 61.0 inches; weight: 80.0 pounds). Patient would get sick three times a year during spring, summer and winter. Patient received nasal FLUMIST (intranasal) in 2011 and 2012 and nasal FLUMIST QUADRIVALENT (intranasal) in 2013, 2014 and 2015 so patient would get the flu. The patient stated that since taking the FLUMIST, her daughter would get a cold once a year instead of three times a year prior to starting the FLUMIST. She also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration. The outcome of the events of cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) was unknown. The company physician assessed the events of cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) to be non-serious. Corrected report on 08-Nov-2016: Suspect product FLUMIST was added. Dosing regimen was corrected. Associated case ID was added. Narrative updated.
Sex: F
Vaccine: FLUN3
Symptoms: Circumstance or information capable of leading to medication error, Nasopharyngitis, Rhinorrhoea
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient (height: 69.0 inches; weight: 165.0 pounds). The patient received nasal FLUMIST (intranasal) in 2011 and 2012, nasal FLUMIST QUADRIVALENT (intranasal) in 2013, 2014 and 2015 so patient would not get the flu. The dose was unknown. Patient stated that since taking the FLUMIST, she would get a cold once a year instead of 3 times a year prior to starting the FLUMIST, also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration. The outcome of cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) was unknown. The company physician assessed cold and would sniff after administration of FLUMIST or the vaccine would run out from the nose after administration (medication error) to be non serious. Corrected report on 08-Nov-2016: Suspect product FLUMIST QUADRIVALENT was added. Dosing regimen was corrected. Associated case ID was added. Narrative updated.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Anxiety, Crying, Lip swelling, Urticaria
Clinical narrative: 7 minutes post vaccines, patient's mother informed nurse of patients upper lip swelling. Dr. notified. Pt. crying and anxious. Whelps to face, neck and chest. Administered EPI JR, 10 mg IV Solu-Medrol, 10 IV diphenhydramine. 911 called and transferred to hospital.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Blood culture negative, CSF culture negative, Chills, Enterovirus test negative, Headache
Clinical narrative: Began developing a fever and headache that progressively increased in severity over the couple hours in the evening and became significant enough he came to the ED. He presented with a 40 degree C fever, chills, rigors, and diaphoresis. He experienced a mild fever last year when he received the flu vaccine. No infectious source found. Treated symptomatically with ondansetron, morphine, and diphenhydramine, and dexamethasone. Given empiric antibiotics for a day. Discharged on the 10/24 with symptoms being resolved.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Influenza virus test negative, Polymerase chain reaction, Pyrexia
Clinical narrative: Began developing a fever and headache that progressively increased in severity over the couple hours in the evening and became significant enough he came to the ED. He presented with a 40 degree C fever, chills, rigors, and diaphoresis. He experienced a mild fever last year when he received the flu vaccine. No infectious source found. Treated symptomatically with ondansetron, morphine, and diphenhydramine, and dexamethasone. Given empiric antibiotics for a day. Discharged on the 10/24 with symptoms being resolved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, Itching, Swelling at injection site.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient reports pain, swelling, warmth at injection site beginning 2-3 days after Tdap injection was given. Reported feverishness, temperature was not taken by patient. Swelling and redness at location of bicep and elbow on day patient seen in clinic, no redness at injection site on 1/3/17.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Patient reports pain, swelling, warmth at injection site beginning 2-3 days after Tdap injection was given. Reported feverishness, temperature was not taken by patient. Swelling and redness at location of bicep and elbow on day patient seen in clinic, no redness at injection site on 1/3/17.
Age: 22.0
Sex: M
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site warmth, Malaise
Clinical narrative: Mild rash warm erythematous, non-indurated patch upper 11 cm x 6 cm at (L) deltoid upper area. Also c/o nausea, fatigue, malaise. "I feel sick".
Age: 22.0
Sex: M
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Nausea
Clinical narrative: Mild rash warm erythematous, non-indurated patch upper 11 cm x 6 cm at (L) deltoid upper area. Also c/o nausea, fatigue, malaise. "I feel sick".
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Received PNEUMOVAX 1-3-17. Wife also received and had no problem. Said husbands was given in the back of the arm and had pain, swelling, redness in arm and pain in shoulder. Advised ice and supervisor will contact pt.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient said that his arm (left arm) was hurting really bad and he had to go to the emergency room and they told him to take ADVIL (ibuprofen) and TYLENOL and ice. The left arm was where he got his PNEUMOVAX 23.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Erythema, Head injury, Syncope
Clinical narrative: Fainting spell while standing, approximately 2 minutes after receiving vaccines. Client hit back of head against wall. Recovered in less then 5 minutes. Remained laying with lower extremities elevated. BP 102/82, HR-64, Resp. 20, Gave lollipops (suckers). Redness without edema to back of head. Ice pack applied to head. Refused further treatment (mother).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pruritus, Rash erythematous
Clinical narrative: Baseball size bright red rash - severe itching. Bruising in same area.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Fibromyalgia, Myalgia
Clinical narrative: Patient had PREVNAR and FLUAD on 11-14-16. On 11-17-16 patient experienced severe muscle aches. She saw physician on 11-28-16 and was given naproxen 500 mg. She still had severe aches. Saw physician on 12-15-16 and was given alprazolam 0.5 mg. Patient contacted me on 1-3-17 and said muscle ache severe - I contacted MD on 1-3-17, MD notes show pain is from fibromyalgia and doesn't mention vaccination reactions.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: A rash developed on right arm where MENVEO vaccine was administered. Patient describes it as itchy. Prescribed diphenhydramine.
Age: 30.0
Sex: F
Vaccine: FLU4, TD, TYP
Symptoms: Injection site pain, Pain
Clinical narrative: (R) shoulder became sore on 12/16/16 - had pain with movement - no swelling redness or heat in deltoid or joint. Pt. seen on 12/30/16 - pain has decreased and had gained more ROM in joint - no deformity. Treated with 40 mg prednisone x 5 days.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received injection and was up walking when she fainted after 5 min.
Age: 12.0
Sex: M
Vaccine: FLU4, MENHIB, TDAP
Symptoms: Erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Left arm swelling at Tdap site x 2 days, since shortly after administered. Arm is red and swollen but not painful. Treated with prn cool compress, ibuprofen, and Benadryl. Given prophylactic clindamycin 300mg TID.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Injection site discolouration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Chicken Pox Vaccine. Site of injection became hot to the touch, swelled to the size of a golf ball and became black and blue.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Upper respiratory tract infection
Clinical narrative: Chicken Pox Vaccine. Site of injection became hot to the touch, swelled to the size of a golf ball and became black and blue.
Age: 30.0
Sex: M
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Antibody test, Blister, Full blood count, HIV test, Pyrexia
Clinical narrative: Patient received Varicella, Tdap, and TWINRIX vaccines on 12/08/2016.  On 12/24/16 experienced itchy rash, fever while traveling. Patient developed clear fluid filled blisters with suspected fever.  No rash in mouth, on hands or on feet. Patient reported that fever lasted 3 days. Had negative titer for varicella prior to vaccination.  Patient called doctor on 12/26/16.  Acyclovir was overnighted to him.  Only taking Acyclovir 400 QID, not consistently.  Started on medication on 12/29/16 - 6-7 days ago. Called clinic to report illness, visited clinic and examined by Dr. Had scattered lesions- all crusted.  No oral or palmar rash.  Lungs clear.  No rales. No rhonchi. No wheezing. Probably Varicella infection post vaccination diagnosed with Varicella titer to be testd 4 weeks after initial dose. Patient no longer infectious, lesions crusted.
Age: 30.0
Sex: M
Vaccine: HEPAB, TDAP, VARCEL
Symptoms: Rash pruritic, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Patient received Varicella, Tdap, and TWINRIX vaccines on 12/08/2016.  On 12/24/16 experienced itchy rash, fever while traveling. Patient developed clear fluid filled blisters with suspected fever.  No rash in mouth, on hands or on feet. Patient reported that fever lasted 3 days. Had negative titer for varicella prior to vaccination.  Patient called doctor on 12/26/16.  Acyclovir was overnighted to him.  Only taking Acyclovir 400 QID, not consistently.  Started on medication on 12/29/16 - 6-7 days ago. Called clinic to report illness, visited clinic and examined by Dr. Had scattered lesions- all crusted.  No oral or palmar rash.  Lungs clear.  No rales. No rhonchi. No wheezing. Probably Varicella infection post vaccination diagnosed with Varicella titer to be testd 4 weeks after initial dose. Patient no longer infectious, lesions crusted.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Blood potassium decreased, Blood test, Dehydration, Urinary tract infection
Clinical narrative: Patient went to the emergency room either 12/31/16 or 01/01/17, she is uncertain. She reported she was diagnosed with a urinary tract infection, low k+ and dehydration. And showed the MD her arm from the TDAP but the doctor did not remark on it.
Age: 1.42
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Skin is warm. There is erythema (swelling on the left thigh where patient had the shots, 2 erythematous area: 1 cm next to a 3 X 2 cm area. minimal warmness, non-tenderness). Treatment: Tylenol or ibuprofen prn for pain. Cool compress.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Peripheral swelling
Clinical narrative: Redness/swelling spreading down vaccinated arm onto chest. Significant edema present at posterior elbow into forearm.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma
Clinical narrative: The patient developed a hematoma under her skin at the site of the injection after the vaccine was administered.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Decreased appetite, Depression
Clinical narrative: September 30, 2016-About 4:00 PM I received the FLUZONE HIGH-DOSE vaccine at Pharmacy. Within an hour my arm was sore and a lump had developed around the injection site. The soreness interrupted my sleep and worsened throughout the night. October 1, 2016-After getting up I had increasing discomfort in both arms and my lower back and hips. It was the day of our town-wide garage sale and lower-back pain caused walking to become so painful that I returned home and went to bed, where I remained for two days. I developed a fever and aching pain around and behind my right eye. I was mildly nauseated and had little appetite. October 2, 2016-The pain intensified, I could not sleep because of the back, leg and pain in both shoulder. My joints became so stiff that I could not bend over, step into the tub or dress myself. My fatigue was so overwhelming that I could barely move and I felt depressed. October 4, 2016-The fever went away, my eye stopped hurting. But the pain continued, and I had cramps in my legs. Extreme fatigue and depression continued. I assumed it was a reaction to the shot which would run its course. Yet it continued, the pain altering somewhat in its location and severity over the next two weeks. Friday, October 14, 2016-I called Dr.'s office and described my symptom to the Nurse, asking her to relay them to Dr. His response was that my symptoms were most likely a flu-shot reaction and instructed me to take TYLENOL and check in on Monday, October 17. On Monday, October 17, I felt for the first time as if the symptoms were measurably improved, and informed Dr's office of that. I was preparing for a trip north which would last for at least two weeks. Unfortunately the improvement I experienced was simply the beginning of a pattern in which the symptoms appear to be dissipating only to return stronger than ever. Sleep was nearly impossible as pain in both shoulders and my hips and back was worsened with each movement. The stiffness and muscle soreness would appear to be lessening for several days only to return in full force, once again flattening me with pain, restricted motion, fatigue, depression and generalized discomfort. I cut my northern visit short to return as I was now concerned that whatever was causing my symptoms might be degenerative. November 18, 2016-I had an appointment with Dr. He performed an evaluation, ordered blood work, and prescribed Prednisone. The Prednisone alleviated my symptoms. November 28, 2016-Appointment with Dr. who diagnosed my condition as Polymyalgia Rheumatica. I am to return to his office for a follow-up on January 9, 2017.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Eye pain, Fatigue, Gait disturbance, Injection site mass
Clinical narrative: September 30, 2016-About 4:00 PM I received the FLUZONE HIGH-DOSE vaccine at Pharmacy. Within an hour my arm was sore and a lump had developed around the injection site. The soreness interrupted my sleep and worsened throughout the night. October 1, 2016-After getting up I had increasing discomfort in both arms and my lower back and hips. It was the day of our town-wide garage sale and lower-back pain caused walking to become so painful that I returned home and went to bed, where I remained for two days. I developed a fever and aching pain around and behind my right eye. I was mildly nauseated and had little appetite. October 2, 2016-The pain intensified, I could not sleep because of the back, leg and pain in both shoulder. My joints became so stiff that I could not bend over, step into the tub or dress myself. My fatigue was so overwhelming that I could barely move and I felt depressed. October 4, 2016-The fever went away, my eye stopped hurting. But the pain continued, and I had cramps in my legs. Extreme fatigue and depression continued. I assumed it was a reaction to the shot which would run its course. Yet it continued, the pain altering somewhat in its location and severity over the next two weeks. Friday, October 14, 2016-I called Dr.'s office and described my symptom to the Nurse, asking her to relay them to Dr. His response was that my symptoms were most likely a flu-shot reaction and instructed me to take TYLENOL and check in on Monday, October 17. On Monday, October 17, I felt for the first time as if the symptoms were measurably improved, and informed Dr's office of that. I was preparing for a trip north which would last for at least two weeks. Unfortunately the improvement I experienced was simply the beginning of a pattern in which the symptoms appear to be dissipating only to return stronger than ever. Sleep was nearly impossible as pain in both shoulders and my hips and back was worsened with each movement. The stiffness and muscle soreness would appear to be lessening for several days only to return in full force, once again flattening me with pain, restricted motion, fatigue, depression and generalized discomfort. I cut my northern visit short to return as I was now concerned that whatever was causing my symptoms might be degenerative. November 18, 2016-I had an appointment with Dr. He performed an evaluation, ordered blood work, and prescribed Prednisone. The Prednisone alleviated my symptoms. November 28, 2016-Appointment with Dr. who diagnosed my condition as Polymyalgia Rheumatica. I am to return to his office for a follow-up on January 9, 2017.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint stiffness, Limb discomfort, Mobility decreased, Muscle spasms
Clinical narrative: September 30, 2016-About 4:00 PM I received the FLUZONE HIGH-DOSE vaccine at Pharmacy. Within an hour my arm was sore and a lump had developed around the injection site. The soreness interrupted my sleep and worsened throughout the night. October 1, 2016-After getting up I had increasing discomfort in both arms and my lower back and hips. It was the day of our town-wide garage sale and lower-back pain caused walking to become so painful that I returned home and went to bed, where I remained for two days. I developed a fever and aching pain around and behind my right eye. I was mildly nauseated and had little appetite. October 2, 2016-The pain intensified, I could not sleep because of the back, leg and pain in both shoulder. My joints became so stiff that I could not bend over, step into the tub or dress myself. My fatigue was so overwhelming that I could barely move and I felt depressed. October 4, 2016-The fever went away, my eye stopped hurting. But the pain continued, and I had cramps in my legs. Extreme fatigue and depression continued. I assumed it was a reaction to the shot which would run its course. Yet it continued, the pain altering somewhat in its location and severity over the next two weeks. Friday, October 14, 2016-I called Dr.'s office and described my symptom to the Nurse, asking her to relay them to Dr. His response was that my symptoms were most likely a flu-shot reaction and instructed me to take TYLENOL and check in on Monday, October 17. On Monday, October 17, I felt for the first time as if the symptoms were measurably improved, and informed Dr's office of that. I was preparing for a trip north which would last for at least two weeks. Unfortunately the improvement I experienced was simply the beginning of a pattern in which the symptoms appear to be dissipating only to return stronger than ever. Sleep was nearly impossible as pain in both shoulders and my hips and back was worsened with each movement. The stiffness and muscle soreness would appear to be lessening for several days only to return in full force, once again flattening me with pain, restricted motion, fatigue, depression and generalized discomfort. I cut my northern visit short to return as I was now concerned that whatever was causing my symptoms might be degenerative. November 18, 2016-I had an appointment with Dr. He performed an evaluation, ordered blood work, and prescribed Prednisone. The Prednisone alleviated my symptoms. November 28, 2016-Appointment with Dr. who diagnosed my condition as Polymyalgia Rheumatica. I am to return to his office for a follow-up on January 9, 2017.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal discomfort, Musculoskeletal pain, Nausea, Pain, Pain in extremity
Clinical narrative: September 30, 2016-About 4:00 PM I received the FLUZONE HIGH-DOSE vaccine at Pharmacy. Within an hour my arm was sore and a lump had developed around the injection site. The soreness interrupted my sleep and worsened throughout the night. October 1, 2016-After getting up I had increasing discomfort in both arms and my lower back and hips. It was the day of our town-wide garage sale and lower-back pain caused walking to become so painful that I returned home and went to bed, where I remained for two days. I developed a fever and aching pain around and behind my right eye. I was mildly nauseated and had little appetite. October 2, 2016-The pain intensified, I could not sleep because of the back, leg and pain in both shoulder. My joints became so stiff that I could not bend over, step into the tub or dress myself. My fatigue was so overwhelming that I could barely move and I felt depressed. October 4, 2016-The fever went away, my eye stopped hurting. But the pain continued, and I had cramps in my legs. Extreme fatigue and depression continued. I assumed it was a reaction to the shot which would run its course. Yet it continued, the pain altering somewhat in its location and severity over the next two weeks. Friday, October 14, 2016-I called Dr.'s office and described my symptom to the Nurse, asking her to relay them to Dr. His response was that my symptoms were most likely a flu-shot reaction and instructed me to take TYLENOL and check in on Monday, October 17. On Monday, October 17, I felt for the first time as if the symptoms were measurably improved, and informed Dr's office of that. I was preparing for a trip north which would last for at least two weeks. Unfortunately the improvement I experienced was simply the beginning of a pattern in which the symptoms appear to be dissipating only to return stronger than ever. Sleep was nearly impossible as pain in both shoulders and my hips and back was worsened with each movement. The stiffness and muscle soreness would appear to be lessening for several days only to return in full force, once again flattening me with pain, restricted motion, fatigue, depression and generalized discomfort. I cut my northern visit short to return as I was now concerned that whatever was causing my symptoms might be degenerative. November 18, 2016-I had an appointment with Dr. He performed an evaluation, ordered blood work, and prescribed Prednisone. The Prednisone alleviated my symptoms. November 28, 2016-Appointment with Dr. who diagnosed my condition as Polymyalgia Rheumatica. I am to return to his office for a follow-up on January 9, 2017.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Polymyalgia rheumatica, Pyrexia, Sleep disorder, Vaccination complication
Clinical narrative: September 30, 2016-About 4:00 PM I received the FLUZONE HIGH-DOSE vaccine at Pharmacy. Within an hour my arm was sore and a lump had developed around the injection site. The soreness interrupted my sleep and worsened throughout the night. October 1, 2016-After getting up I had increasing discomfort in both arms and my lower back and hips. It was the day of our town-wide garage sale and lower-back pain caused walking to become so painful that I returned home and went to bed, where I remained for two days. I developed a fever and aching pain around and behind my right eye. I was mildly nauseated and had little appetite. October 2, 2016-The pain intensified, I could not sleep because of the back, leg and pain in both shoulder. My joints became so stiff that I could not bend over, step into the tub or dress myself. My fatigue was so overwhelming that I could barely move and I felt depressed. October 4, 2016-The fever went away, my eye stopped hurting. But the pain continued, and I had cramps in my legs. Extreme fatigue and depression continued. I assumed it was a reaction to the shot which would run its course. Yet it continued, the pain altering somewhat in its location and severity over the next two weeks. Friday, October 14, 2016-I called Dr.'s office and described my symptom to the Nurse, asking her to relay them to Dr. His response was that my symptoms were most likely a flu-shot reaction and instructed me to take TYLENOL and check in on Monday, October 17. On Monday, October 17, I felt for the first time as if the symptoms were measurably improved, and informed Dr's office of that. I was preparing for a trip north which would last for at least two weeks. Unfortunately the improvement I experienced was simply the beginning of a pattern in which the symptoms appear to be dissipating only to return stronger than ever. Sleep was nearly impossible as pain in both shoulders and my hips and back was worsened with each movement. The stiffness and muscle soreness would appear to be lessening for several days only to return in full force, once again flattening me with pain, restricted motion, fatigue, depression and generalized discomfort. I cut my northern visit short to return as I was now concerned that whatever was causing my symptoms might be degenerative. November 18, 2016-I had an appointment with Dr. He performed an evaluation, ordered blood work, and prescribed Prednisone. The Prednisone alleviated my symptoms. November 28, 2016-Appointment with Dr. who diagnosed my condition as Polymyalgia Rheumatica. I am to return to his office for a follow-up on January 9, 2017.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Confusional state, Pallor, Posture abnormal, Throat irritation
Clinical narrative: Patient complained of scratchy throat, became pale, confused and weak  then slumped over in chair unresponsive. 911 dispatched EMTs that spent about 30 minutes with him and sent him home with his mom. Her recovered 100% and was okay all night and next day.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient complained of scratchy throat, became pale, confused and weak  then slumped over in chair unresponsive. 911 dispatched EMTs that spent about 30 minutes with him and sent him home with his mom. Her recovered 100% and was okay all night and next day.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram abnormal, Hypoaesthesia, Muscle spasms, Radiculitis brachial
Clinical narrative: 3days after shot. Muscle, nerve spasms went on steroid, gabapentin, LYRICA, had EMG-EMG states acute brachial neuritis none feeling in thumb, 2st finger (left).
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Itching that broke out into rash on back, chest, face and neck. Symptoms started 1-2 hrs after receiving vaccine.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Atrophy, Facial paresis, Muscular weakness, Myalgia, Peripheral swelling
Clinical narrative: Extreme muscle pain and weakness, swelling of face and arms (3 months) lingering pain and weakness of face, arms, and legs. Atrophy of arms and lesions on same.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Skin lesion, Swelling face
Clinical narrative: Extreme muscle pain and weakness, swelling of face and arms (3 months) lingering pain and weakness of face, arms, and legs. Atrophy of arms and lesions on same.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer (Manufacturer control # 20166538324) and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced histamine related reactions. The outcome of histamine related reactions was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cough, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: This is a spontaneous report from a contactable consumer who reported. A 75-year-old other ethnic group female patient received PREVNAR 13, via an unspecified route of administration at single dose in the left arm on 01Dec2016 for immunisation. Medical history included high blood pressure. Concomitant medications were not reported. In Dec2016, the patient experienced fever with outcome of recovering, swelling of upper part of the arm where the injection was given with outcome of recovering, redness and painful to the touch with outcome of unknown, vomiting with outcome of unknown, lost appetite with outcome of unknown, diarrhoea with outcome of unknown, lost nine pounds with outcome of unknown, chest congestion with outcome of not recovered, bad cold or flu with outcome of not recovered, lack of energy with outcome of unknown, she not able to move her arms even slowly with outcome of unknown, coughing with outcome of not recovered. Therapeutic measures were taken as a result of the events included some antibiotics like Clindamycin.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza, Injection site swelling, Mobility decreased, Nasopharyngitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported. A 75-year-old other ethnic group female patient received PREVNAR 13, via an unspecified route of administration at single dose in the left arm on 01Dec2016 for immunisation. Medical history included high blood pressure. Concomitant medications were not reported. In Dec2016, the patient experienced fever with outcome of recovering, swelling of upper part of the arm where the injection was given with outcome of recovering, redness and painful to the touch with outcome of unknown, vomiting with outcome of unknown, lost appetite with outcome of unknown, diarrhoea with outcome of unknown, lost nine pounds with outcome of unknown, chest congestion with outcome of not recovered, bad cold or flu with outcome of not recovered, lack of energy with outcome of unknown, she not able to move her arms even slowly with outcome of unknown, coughing with outcome of not recovered. Therapeutic measures were taken as a result of the events included some antibiotics like Clindamycin.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Respiratory tract congestion, Tenderness, Vomiting, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer who reported. A 75-year-old other ethnic group female patient received PREVNAR 13, via an unspecified route of administration at single dose in the left arm on 01Dec2016 for immunisation. Medical history included high blood pressure. Concomitant medications were not reported. In Dec2016, the patient experienced fever with outcome of recovering, swelling of upper part of the arm where the injection was given with outcome of recovering, redness and painful to the touch with outcome of unknown, vomiting with outcome of unknown, lost appetite with outcome of unknown, diarrhoea with outcome of unknown, lost nine pounds with outcome of unknown, chest congestion with outcome of not recovered, bad cold or flu with outcome of not recovered, lack of energy with outcome of unknown, she not able to move her arms even slowly with outcome of unknown, coughing with outcome of not recovered. Therapeutic measures were taken as a result of the events included some antibiotics like Clindamycin.