chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025066, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 90 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. Nurse reported that patient received FLUVIRIN that was 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025067, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 52 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025068, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to an 11 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose on 18 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025069, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 65 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025070, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 75 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 29 Oct 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025071, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 71 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025072, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 61 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 07 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025073, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 74 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025074, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 32-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025075, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 81-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025076, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 15-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 18 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025057, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025058, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 59 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025059, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 79 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscular at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025060, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 83 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 07 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse on 15 October 2015 and additional information received from nurse in the United States on 17 October 2015. This case is linked with case number: 2015SA164148 (same reporter, same vaccine, same lot number). This case involves 10 patients (age not reported and gender reported as both males and females) who were vaccinated with a dose of Fluzone QIV (batch number: U5319AA, expiration date: 30 June 2016, dose and dose number were not reported) subcutaneously in deltoid (left or right arm below) on October 2015 (reported as "12 October 2015 and 13 October 2015"). Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at time of vaccination were not reported. On October 2015 (reported as "12 October 2015 and 13 October 2015") following the vaccination, the patients developed site redness swelling, and lump at site some with softball sized lump. It was reported that all patients who developed reactions were heavier set. Patients required ER or doctor visit whereas, two patients seen by medical group for observation. Laboratory investigation was not reported. The patient did not receive any corrective treatment. The patient was not recovered from events. Follow up information received from a Nurse in on 22 January 2016. This case involves a 45 years old female patient (reported as in her mid-forties) who was vaccinated with Fluzone QIV vaccine on 12 October 2015. The patient had experienced discomfort, swelling, redness and felt shaky on an unspecified date. The patient had received Ibuprofen as corrective treatment for event discomfort. The patient was seen by physician on 14 October 2015. The physician reported that, the patient had moderately severe reaction to the flu immunization. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Nervousness, Swelling
Clinical narrative: Initial unsolicited report received from a nurse on 15 October 2015 and additional information received from nurse in the United States on 17 October 2015. This case is linked with case number: 2015SA164148 (same reporter, same vaccine, same lot number). This case involves 10 patients (age not reported and gender reported as both males and females) who were vaccinated with a dose of Fluzone QIV (batch number: U5319AA, expiration date: 30 June 2016, dose and dose number were not reported) subcutaneously in deltoid (left or right arm below) on October 2015 (reported as "12 October 2015 and 13 October 2015"). Pre-existing physician diagnosed allergies, birth defects, medical conditions and Illness at time of vaccination were not reported. On October 2015 (reported as "12 October 2015 and 13 October 2015") following the vaccination, the patients developed site redness swelling, and lump at site some with softball sized lump. It was reported that all patients who developed reactions were heavier set. Patients required ER or doctor visit whereas, two patients seen by medical group for observation. Laboratory investigation was not reported. The patient did not receive any corrective treatment. The patient was not recovered from events. Follow up information received from a Nurse in on 22 January 2016. This case involves a 45 years old female patient (reported as in her mid-forties) who was vaccinated with Fluzone QIV vaccine on 12 October 2015. The patient had experienced discomfort, swelling, redness and felt shaky on an unspecified date. The patient had received Ibuprofen as corrective treatment for event discomfort. The patient was seen by physician on 14 October 2015. The physician reported that, the patient had moderately severe reaction to the flu immunization. List of documents held by sender: none.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Erythematous rash, maculopapular rash that started on his face and abdomen which now is covering his entire body.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Myositis, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Patient received the flu vaccine in November 2015. Immediately had pain. Tenderness did not resolve. Reported pain in January. MRI of upper left arm demonstrated findings suggestive of bursitis or myositis which the radiologist suggested could be infectious in etiology.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Patient received the flu vaccine in November 2015. Immediately had pain. Tenderness did not resolve. Reported pain in January. MRI of upper left arm demonstrated findings suggestive of bursitis or myositis which the radiologist suggested could be infectious in etiology.
Age: 1.09
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Pt developed a white raised hive 12mm in diameter with erythema surrounding the area on the left thigh where the varicella vaccine had been administered SC.  The area of erythema was approximately 90mm in diameter.  The area of erythema was warm and slightly hardened to the touch.  2.5mL of diphenhydramine was administered PO at 1650.  At 1700, hive was no longer white (became pink) and began to diminish in height. Erythema began to diminish.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Chills, Headache, Myalgia, Sleep disorder
Clinical narrative: Around 8:00 PM (~7 hours after administration of rabies vaccine #2), I developed systemic myalgias and arthralgias, headache, and rigors. The symptoms worsened over the next hour, so I took ibuprofen and went to bed. I woke up in the middle of the night (~3 AM) with persistent symptoms that had not lessened in severity. I took ibuprofen again and went back to sleep. When I awoke around 7 AM, the symptoms had resolved. Of note, I had received the first injection of the rabies vaccination series the week prior and had no adverse reaction.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient came back about thirty to forty minutes after vaccination stating severe itching.  Upon visual inspection there was redness (about size of fifty cent piece). Gave patient an ice pack to place on area and recommended Benadryl.  He held ice pack for 15 minutes and took Benadryl patient said symptoms improved.  Felt fine to go home.  Educated patient on signs and symptoms of anaphylaxis.  Called patient at 7:00PM (6 hours after) and he said he was just fine.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: He woke up the next morning with soreness and redness at the site of the injection (Left Deltoid). He had a doctor appointment that morning for an unrelated situation and the MD told him it looked like cellulitis and that he should go to the hospital.
Age: 1.3
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash generalised
Clinical narrative: He received varicella vaccine 1-19-16 during his 15 month well check. He developed bumps all over his body on Monday.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Fatigue, Flushing, Headache
Clinical narrative: Fatigue, muscle aches, muscle spasms, headache, back pain, abdominal pain, neck pain, flushing, tachycardia.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Myalgia, Neck pain, Tachycardia, Urobilinogen urine increased
Clinical narrative: Fatigue, muscle aches, muscle spasms, headache, back pain, abdominal pain, neck pain, flushing, tachycardia.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count increased
Clinical narrative: Fatigue, muscle aches, muscle spasms, headache, back pain, abdominal pain, neck pain, flushing, tachycardia.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypoaesthesia, Pain, Urticaria
Clinical narrative: Hives noted within 1 hour of vaccination. No wheezing alert. Given Epipen .15, BENADRYL 20 mg prednisolone 20 mg. Sats 99 HR 88. Urticaria numbing pain to discharge, discharge to ER via EMT.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Nausea
Clinical narrative: Had fatigue, fever, chills, HA, nausea, evening vaccine given. Redness around vaccine site involving upper arm to elbow. Fever to 100 degrees F.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Had fatigue, fever, chills, HA, nausea, evening vaccine given. Redness around vaccine site involving upper arm to elbow. Fever to 100 degrees F.
Age: 5.0
Sex: U
Vaccine: DTAP, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction reported by patient. Patient received extra dose of DTAP and MMRV.
Age: 1.93
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC13
Symptoms: Generalised tonic-clonic seizure, Postictal state
Clinical narrative: Given DTaP, Hep A, Flu, PCV13. That night had first ever GTC seizure, postictal afterwards. Questionable fever/OM by ER but none noted at WCE that day. Suspect DTaP.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Chills
Clinical narrative: Chills multiple times daily for six weeks.
Age: 68.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of injection site pain in a 68-year-old female patient who received FLUARIX (batch number GB749, expiry date 22nd June 2016). Concurrent medical conditions included heart disease, unspecified. Concomitant products included PREVENAR 13. On 23rd November 2015, the patient received FLUARIX (intramuscular) 0.5 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. On 12th January 2016, the patient reported that she continued experiencing pain the right arm (injection site pain). The reported batch number (6B749) of FLUARIX vaccine did not exist and was updated to GB749 as per sales database.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2014US025061, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 60 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 29 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025062, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 52-year-old male patient. historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree D during the excursion. No adverse event reported following this medication error (incorrect storage of drug).
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025063, is an initial spontaneous report from a nurse on 09 Dec 2014. This report refers to a 55-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN  (batch number: 145701) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between F during excursion. No adverse events reported after the maladministration.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025064, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to an 86 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursion began around 16 Oct 14. 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursion. No adverse event was reported following this maladministration. No further information was provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Sluggishness, Urticaria
Clinical narrative: Hives on arm that received shot. Top of arm, armpit and side of breast ached and were sore to the touch. General feeling of sluggishness. Took Benadryl and it went away in two days.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Anti-thyroid antibody positive, Asthenia, Autoimmune thyroiditis, Blood cholesterol increased, Blood thyroid stimulating hormone increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Blood triglycerides normal, Fluid retention, High density lipoprotein decreased, Hypothyroidism, Joint stiffness
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Low density lipoprotein increased, Metabolic disorder, Obesity, Sexual dysfunction, Thyroxine increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Tri-iodothyronine free increased, Weight increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 1.11
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Chills, Drooling, Headache, Pyrexia, Rash
Clinical narrative: Started out with fever and chills, which lasted for 3 full days. On 1/27/16, patient developed a measles-like rash on face, inside mouth, diaper area, neck, hands, and feet. Minimal rash on torso and back. She also developed chicken pox sores. She had headache and very swollen cheeks with large amount of drooling. The rash and chicken pox are not completely gone and it is now 2/3/2016.
Age: 1.11
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Rash morbilliform, Swelling face, Varicella post vaccine
Clinical narrative: Started out with fever and chills, which lasted for 3 full days. On 1/27/16, patient developed a measles-like rash on face, inside mouth, diaper area, neck, hands, and feet. Minimal rash on torso and back. She also developed chicken pox sores. She had headache and very swollen cheeks with large amount of drooling. The rash and chicken pox are not completely gone and it is now 2/3/2016.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Anti-thyroid antibody positive, Asthenia, Autoimmune thyroiditis, Blood cholesterol increased, Blood thyroid stimulating hormone increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Blood triglycerides normal, Fluid retention, High density lipoprotein decreased, Hypothyroidism, Joint stiffness
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Low density lipoprotein increased, Metabolic disorder, Obesity, Sexual dysfunction, Thyroxine increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Tri-iodothyronine free increased, Weight increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, TYP
Symptoms: Anti-thyroid antibody positive, Autoimmune thyroiditis, Blood glucose normal, Blood thyroid stimulating hormone increased, Blood triglycerides normal
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, TYP
Symptoms: Fluid retention, High density lipoprotein normal, Hypothyroidism, Joint stiffness, Lipids
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, TYP
Symptoms: Low density lipoprotein increased, Malaise, Metabolic disorder, Non-high-density lipoprotein cholesterol, Obesity
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, TYP
Symptoms: Sexual dysfunction, Thyroxine free increased, Tri-iodothyronine free normal, Weight increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: MEN
Symptoms: Anti-thyroid antibody positive, Asthenia, Autoimmune thyroiditis, Blood cholesterol increased, Blood thyroid stimulating hormone increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: MEN
Symptoms: Blood triglycerides normal, Fluid retention, High density lipoprotein decreased, Hypothyroidism, Joint stiffness
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: MEN
Symptoms: Low density lipoprotein increased, Metabolic disorder, Obesity, Sexual dysfunction, Thyroxine increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Age: 23.0
Sex: M
Vaccine: MEN
Symptoms: Tri-iodothyronine free increased, Weight increased
Clinical narrative: Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of RECOMBIVAX HB (lot # L001456 with expiry date 22-OCT-2016, lot # reported as L020216 with expiry date 17-SEP-2016 and lot # L025738 with expiry date 14-AUG-2017; route was not reported), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates, the patient received two doses of ZOSTAVAX (lot #, dose and route were unspecified). No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a male patient in his 70's. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2009, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, (dose, injection site, lot number and expiration date were not reported). On an unknown date in approximately January 2016 (reported as "last week"), the patient was revaccinated with ZOSTAVAX subcutaneously, (dose, injection site, lot number and expiration date were not reported). No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of improperly stored ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of ZOSTAVAX underwent temperature excursions at 7 Fahrenheit degrees, for unknown time frames. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: This spontaneous report as received from a 69 year old female registered nurse refers to herself. The patient's current conditions included herpes simplex and mitral valve prolapse. The patient had no known drug reactions. On 11-JAN-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# unknown) at an unknown pharmacy. No concomitant therapies were reported. On 12-JAN-2016, the patient experienced a runny nose, dizziness, nausea and headache. The patient took a dose of over the counter SUDAFED PE with acetaminophen on the same day at an unspecified exact dose and it helped her symptoms. On an unspecified date in January 2016 the patient experienced redness (diameter of the reddened area was unspecified) and warmth at the injection site of ZOSTAVAX vaccination. The patient did not seek any medical attention. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: This spontaneous report as received from a 69 year old female registered nurse refers to herself. The patient's current conditions included herpes simplex and mitral valve prolapse. The patient had no known drug reactions. On 11-JAN-2016 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# unknown) at an unknown pharmacy. No concomitant therapies were reported. On 12-JAN-2016, the patient experienced a runny nose, dizziness, nausea and headache. The patient took a dose of over the counter SUDAFED PE with acetaminophen on the same day at an unspecified exact dose and it helped her symptoms. On an unspecified date in January 2016 the patient experienced redness (diameter of the reddened area was unspecified) and warmth at the injection site of ZOSTAVAX vaccination. The patient did not seek any medical attention. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On 01-FEB-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # K020802. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patient were vaccinated orally with unknown doses of ROTATEQ (lot # L022447 with expiry date 26-FEB-2017 and lot # L010837 with expiry date 16-FEB-2017), which were exposed to the temperature of 1.5 degrees Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unknown doses of PEDVAXHIB (lot # L030868, expiry date 09-JUN-2018; route was not reported), which were exposed to the temperature of 1.5 degree Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Mass, Skin warm
Clinical narrative: Pt developed red, hard lump 6 in x 6 in. Pt states that it was hot to touch, these symptoms lasted 5 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (who is a medical assistant) refers to an unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. The healthcare worker reported that multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot # K014548 exp: 27-AUG-2016. The vaccine was stored at 47F and administered within in a time frame of 10 minutes. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Impaired quality of life
Clinical narrative: This spontaneous report as received from a consumer refers to her 13-year-old son with asthma, nut allergy and weakened immune system. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced havoc and lost year of life. The outcome of impaired quality of life was reported as recovered/resolved on an unspecified date. The reporter considered impaired quality of life to be related to GARDASIL. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Skin exfoliation
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 75 year old female patient with unspecified respiratory issues and allergy to unspecified sulfa drug. On 25-JAN-2016 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L025001, exp date: 06-OCT-2016), subcutaneously. Concomitant therapies included SPIRIVA, SEREVENT, HYDROMET, REMERON and PEPCID. On 27-JAN-2016, the patient developed a blister at the injection site. The pharmacist stated one portion of the blistered area appeared as though the skin had fallen and was red underneath, while the rest of the blistered skin was intact. The patient had visited pharmacist. No lab diagnostics studies were performed. The patient had not received any treatment and did not recover from the events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L021214, expiry date 10-JUN-2017, dose and route were unknown). The vaccine experienced a temperature excursions (temperature 15.8 F, time frame: 14 hours and 30 minutes). There was no previous excursions. It was a data logger and back in range. No adverse effect reported. This is one of two reports received from the same source. Additional information is not expected because there was no consent for follow up.
Sex: F
Vaccine: HPV4, VARZOS
Symptoms: Extra dose administered, Product use issue
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent conditions included diabetes mellitus and chronic psoriasis. The patient began receiving ZOSTAVAX and GARDASIL in the beginning of 2007 to cure her chronic psoriasis. The patient's ZOSTAVAX initial vaccination began on an unspecified date in 2007; with another follow-up dose towards end of 2007. The patient then received up to another 7 extra doses of ZOSTAVAX between 2007 and in 2016. During this time frame the patient also received 5 or 6 separate doses of GARDASIL. She stated that the combination and amount of vaccinations had all but 'cured' her acute case of psoriasis. In order to receive the above mentioned treatment, the patient sometimes received each vaccine under an alternate assumed name among others. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Information has been received from a consumer referring to his 60 year old wife. There were no pertinent medical history and drug reactions/allergies. On 11-JAN-2016 the patient was vaccinated with ZOSTAVAX (strength and lot# unspecified, 0.65 ml/single, subcutaneous). Concomitant medication included unspecified blood pressure, cholesterol and anxiety medications. On the same day, the patient experienced a rash/redness with "the size of a quarter at the injection site". The patient did go to seek medical attention via visiting unspecified urgent care and was given doxycycline for the rash. The second day after receiving ZOSTAVAX, the redness became "a large as a ball" and on the third day after receiving ZOSTAVAX, the redness spread to her elbow and was still swollen. The patient did go back to the same unspecified urgent care and was given a second antibiotic, LEVAQUIN. No lab diagnostic studies were performed. The outcome of the events was reported as recovering/resolving. Additional information is not expected as there was no consent to be contacted for the reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On unknown dates the patients were vaccinated with improperly stored doses of M-M-R II (lot # K024035, expiration date 26-NOV-2016, dose and route were unknown). The vaccine experienced a temperature excursion. It was a data logger and back in range. The M-M-R II did not undergo an excursion as per product information (PI). No adverse effect reported. This is one of two reports received from the same source. Additional information is not expected because there was no consent for follow up.
Age: 29.0
Sex: F
Vaccine: HPVX
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. The patient became pregnant with last menstrual period (LMP) of 05-JUL-2015 and expected delivery of date (EDD) of 10-APR-2016. On 29-JAN-2016 (pregnancy at 29 weeks and 4 days), the patient was injected in error with an HPV vaccine (route, dose and lot# were unknown) in the left arm instead of an TDAP vaccine by a nurse in her physician's office (wrong drug administered and exposure during pregnancy). The patient could not identify the specific HPV vaccine. GARDASIL or GARDASIL 9 could not be ruled out (product origin unknown). No adverse effect was reported. The pregnancy outcome was pending. Additional information is not expected as the physician didn't like to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 11-FEB-2015, the patients were vaccinated with PROQUAD (Merck) lot # L031602, expiration date- 18-FEB-2017, which was exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event was reported. The outcome of event was unknown. Temperature was 9F, time frame- less than 1 hour and there was temperature excursion earlier also. This is one of several reports received from the same reporter. Additional information has been requested.