chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Dysphemia, Feeling hot, Gait disturbance, Headache, Memory impairment
Clinical narrative: This spontaneous report as received from a nurse in a physician's office via a company representative refers to a 13 year old female patient. No concurrent condition or medical history reported. On an unknown date in march 2015, the patient was vaccinated with second or third dose of GARDASIL, (lot number K001631 and expiry date 06-NOV-2016) intramuscularly. No concomitant medications were reported. On 12-MAR-2015, within two hours of receiving the GARDASIL the patient started shaking, repeating herself, had a chest discomfort and complained about being hot. The patient sought medical attention and was hospitalized overnight for those events. On an unknown date in 2015, the patient underwent a Computerized axial tomography (CAT scan), Blood work (details unspecified), drug screen and urine analysis the results of which were unknown. The action taken with the therapy with GARDASIL was not applicable. The outcome of the events was reported as recovered on an unknown date in 2015. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Repetitive speech, Tremor, Urine analysis
Clinical narrative: This spontaneous report as received from a nurse in a physician's office via a company representative refers to a 13 year old female patient. No concurrent condition or medical history reported. On an unknown date in march 2015, the patient was vaccinated with second or third dose of GARDASIL, (lot number K001631 and expiry date 06-NOV-2016) intramuscularly. No concomitant medications were reported. On 12-MAR-2015, within two hours of receiving the GARDASIL the patient started shaking, repeating herself, had a chest discomfort and complained about being hot. The patient sought medical attention and was hospitalized overnight for those events. On an unknown date in 2015, the patient underwent a Computerized axial tomography (CAT scan), Blood work (details unspecified), drug screen and urine analysis the results of which were unknown. The action taken with the therapy with GARDASIL was not applicable. The outcome of the events was reported as recovered on an unknown date in 2015. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4, HPV4
Symptoms: Blood test, Chest discomfort, Computerised tomogram, Drug screen, Feeling hot
Clinical narrative: This spontaneous report as received from a nurse in a physician's office via a company representative refers to a 13 year old female patient. No concurrent condition or medical history reported. On an unknown date in march 2015, the patient was vaccinated with second or third dose of GARDASIL, (lot number K001631 and expiry date 06-NOV-2016) intramuscularly. No concomitant medications were reported. On 12-MAR-2015, within two hours of receiving the GARDASIL the patient started shaking, repeating herself, had a chest discomfort and complained about being hot. The patient sought medical attention and was hospitalized overnight for those events. On an unknown date in 2015, the patient underwent a Computerized axial tomography (CAT scan), Blood work (details unspecified), drug screen and urine analysis the results of which were unknown. The action taken with the therapy with GARDASIL was not applicable. The outcome of the events was reported as recovered on an unknown date in 2015. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Tetanus shot and pneumonia shot given on 6/4.  2 hours later pt experienced numbness and tingling in her right arm.  Symptoms have gotten progressively worse over the past few days.  Now hardly able to move her arm.  Severe pain/ numbness/ weakness in R arm and hand.  Neck pain.  Can't hold things or pick them up.  Right handed. Ice compress to injection site, STAT Neurology Referral, Xray ordered, 06/06/2015 Naproxen 500 mg BID with food, off from work. Adviced by provider to go to ER if not seen for a follow up in a timely fashion For A Follow up on Adverse reaction to PNA Vaccine Given at the right Deltod.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Neck pain
Clinical narrative: Tetanus shot and pneumonia shot given on 6/4.  2 hours later pt experienced numbness and tingling in her right arm.  Symptoms have gotten progressively worse over the past few days.  Now hardly able to move her arm.  Severe pain/ numbness/ weakness in R arm and hand.  Neck pain.  Can't hold things or pick them up.  Right handed. Ice compress to injection site, STAT Neurology Referral, Xray ordered, 06/06/2015 Naproxen 500 mg BID with food, off from work. Adviced by provider to go to ER if not seen for a follow up in a timely fashion For A Follow up on Adverse reaction to PNA Vaccine Given at the right Deltod.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Pain in extremity, Paraesthesia, Spinal X-ray abnormal
Clinical narrative: Tetanus shot and pneumonia shot given on 6/4.  2 hours later pt experienced numbness and tingling in her right arm.  Symptoms have gotten progressively worse over the past few days.  Now hardly able to move her arm.  Severe pain/ numbness/ weakness in R arm and hand.  Neck pain.  Can't hold things or pick them up.  Right handed. Ice compress to injection site, STAT Neurology Referral, Xray ordered, 06/06/2015 Naproxen 500 mg BID with food, off from work. Adviced by provider to go to ER if not seen for a follow up in a timely fashion For A Follow up on Adverse reaction to PNA Vaccine Given at the right Deltod.
Age: 55.0
Sex: F
Vaccine: MMR, MNQ, PPV, MEN, MMR, PPV
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: On August 10, 2014 I attended the second day of an annual two-day event. I elected to receive 3 vaccines approximately 30 minutes before the event ended on August 10th.  I indicated that I wanted to receive the meningococcal vaccine, the measle-mumps-rubella vaccine and the Pneumovax. I had written these three vaccines on the intake sheet. I was informed that they had run out of the Pneumovax but they had the pneumonia vaccine that was given to children and it would be OK to receive that one. I was given the patient information sheets for  1) Pneumococcal Conjugate Vaccine  (2/27/2013), MMR Vaccine (4/20/2012) and Meningococcal Vaccines (10/14/2011). The nurse administered all vaccinations. The MMR was administered subcutaneously into the Right upper arm and the meningococcal vaccine into the Right deltoid muscle. I asked that the third vaccination not be given the Left arm because I am Left-handed but the nurse insisted that she had to administer this vaccination into in my Left upper arm (deltoid muscle) and did so. I experienced muscle tenderness and achiness in the left arm initially for about two weeks during which there was mild pain when I attempted to raise my left arm straight up in the air. The muscle tenderness, achiness and inability to raise my left arm straight up in the air or place my left hand behind my back continued for another ten days which I attributed to time spent in a cool, damp environment.  After leaving the cool, damp environment the muscle tenderness and achiness progressed to severe pain with the slightest movement of my left arm in any direction. The severe pain lasted through the month of September, approximately 30 days. The muscle pain and achiness gradually resolved over the next three months and was completely gone by January 2015; however, the inability to raise the left arm straight up in the arm, lift objects with my left hand above shoulder level or place my left hand behind back persisted. It was at this time that I inquired at the local County Health Department information about the vaccines that I had been given in August 2014. At first, January 30, 2015, no information regarding the site of administration or lot numbers was available for any of the three vaccinations because the information had not been entered into the Statewide Immunization System. On February 5, 2015, a fax of the intake sheet revealed handwritten lot numbers for the "pneumonia" vaccine [Merck J010396], MMR [Merck J013316 ] and an illegible sticker for Menactra with a handwritten lot # [44681AA]. The faxed intake sheet indicated that ALL immunizations were given in the right deltoid. Three physicians, a family medicine (03-11-2015), an internal medicine (03-23-2015) and an orthopedic surgeon (04-02-2015) were seen for the left upper extremity problem. Their comments were consistent: unable to abduct beyond 90 degrees, decreased range of motion, adhesive capsulitis, respectively, and all agreed no pain was elicited on examination.  All recommended physical therapy.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chest discomfort, Cough, Oral mucosal eruption, Tongue disorder
Clinical narrative: Pt began to cough, felt chest getting tight, tongue felt thick. She also developed a rash around the mouth. Pt given Benadryl by mother and then presented to our office where she was monitor for one hour more Benadryl was given as the dose given by mom was below the recommended dosage for child's weight. Pt's symptoms completely resolved before pt left the office.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash vesicular, Skin lesion
Clinical narrative: Patient presented to the ED complaining of burning and painful vesicular rash on the C5 dermatome. Patient was discharged from the ED with prescription for Zovirax 600 mg po 5 times a day for 7 days and Neurontin 300 mg po HS. Returned to clinic for follow-up, lesions were in the healing process.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: After the shot 30 days later paralyzed from the neck down which they diagnosed as Guillain Barre from the flu shot (and my case wasn't reported).
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Developed cellulitis at injection site; treated with Kelfex for 5 days.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Chest X-ray, Cough, Decreased appetite, Influenza virus test, Pyrexia
Clinical narrative: Cough, fever and decreased appetite since vaccine was given. Treatment required hospitalization for respiratory distress per dr. Likely one night. Pt received nebulizer with albuterol treatment.
Age: 1.75
Sex: M
Vaccine: HEPA
Symptoms: Respiratory distress, Respiratory syncytial virus test
Clinical narrative: Cough, fever and decreased appetite since vaccine was given. Treatment required hospitalization for respiratory distress per dr. Likely one night. Pt received nebulizer with albuterol treatment.
Age: 9.0
Sex: F
Vaccine: HEP, MMRV
Symptoms: Abdominal pain upper, Lethargy, Pyrexia
Clinical narrative: High fever (103F), severe stomach pains, lethargic.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Slight pain, moderate itching, red warm rash at injection site measured at 14 cm in width with central darker erythema about 4 cm across.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Tachyphrenia
Clinical narrative: Racing Mind/Thoughts, Headaches. These symptoms started the afternoon of 06/17/2015. Mother and Pt returned to Dr office on 06/18/2015 due to symptoms. Advised pt to rest and avoid overstimulation of mental activity until symptoms resolve. Also to stay hydrated and can take OTC Ibuprofen per product label as needed. Spoke with Patients mother and patient on 06/19/2015 AM and Patient stated doing better and symptoms were not as severe.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Papule, Pruritus
Clinical narrative: DISCRETE ITCHY PAPULES EACH LASTING ABOUT 1 WEEK INVOLVING FACE, NECK, ARMS, AND TRUNK BEGINNING DAY AFTER RECEIVING VACCINE.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. On an unknown dates, the patients received improperly stored doses of GARDASIL (batch/lot #, dose, route and site of administration were not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 02-JUN-2015, the patient was vaccinated with improperly stored GARDASIL (route of administration and dose were not reported) (lot # K023432, expiry date: 18-JUN-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: Next day patient report fever/chills/swollen arm. Temp 102.5 on follow up 2-4-2015 patient reports the symptoms resolved with cold compress and time.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed swelling and itching and redness and heat circumferentially around the arm where she got the shot.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Vomiting
Clinical narrative: Vomiting thru out the day.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Rash generalised
Clinical narrative: Generalized rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: THE LEFT ARM WAS SWOLLEN 11 AND HALF IN CENTIMETERS, ITCHY.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Large, raised rash at injection site, about 2 x 3 inches. Doctor advised watching and waiting with ice, Advil, etc. Rash larger than most reactions but not out of the ordinary.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash generalised
Clinical narrative: Generalized rash, slight itchiness to rash areas. No drainage.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Reported burning down the arm.  Developed into soreness beyond typical for IM injection lasting for a month afterward.
Age: 59.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Blister, Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling, heat, 2 blisters; called her PCP he recommended Benadryl, hydrocortisone 1%, and to apply ice.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Rash, Rash pustular, Skin lesion
Clinical narrative: Noticed scalp tenderness in shower 6/13 AM EDT. On 6/17 PM noticed what felt like the beginning of a pustule (zit) on rear of left scalp, and one on back of neck, also left side. 6/18 noticed more sore spots, at ~11:30 PM asked wife to look and see if I was having an acne attack. She said it looked "like a rash." Within the hour I made a tentative lay diagnosis of shingles. Called facility in the morning, and my diagnosis was confirmed by MD at about 11:15 AM. Acyclovir and Norco prescribed. Lesions at back of neck have proliferated markedly since last night/this morning.
Age: 89.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Red and swelling extending from left shoulder halfway down left arm. Dermatologist recommended Claritin, which did not help. Later that night, patient could not sleep due to pain in left wrist. Wrist pain worsened next day and not relieved from Norco or Neurontin. Patient never experienced respiratory symptoms and no fever was observed by daughter.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site pain, Leukocytosis, Tachycardia
Clinical narrative: Tachycardia, pain/cellulitis at site, leukocytosis.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Feeling cold, Feeling drunk, Hypoaesthesia, Mobility decreased
Clinical narrative: Tachycardia, pain/cellulitis at site, leukocytosis.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Tachycardia, pain/cellulitis at site, leukocytosis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patients experience local injection site hot to touch, pain, red, itchy, and swelling, possible cellulitis and was prescribed doxycylcine 100mg qd.
Age: 0.53
Sex: M
Vaccine: HIBV
Symptoms: Crying, Emotional distress, Injection site urticaria, Irritability, Opisthotonus
Clinical narrative: 7 hours after patient received HIB vaccine, he woke up and was "inconsolable". He was arching his back and had a high-pitched cry. Mom stated "I have never heard a child have that type of cry."  The crying lasted for 1 hour (from 11pm until midnight). Then he went back to sleep.  Parents had given him Ibuprofen at around 8:30pm. Mom is concerned that patient arches his back a lot. He has GE reflux so I feel the back arching is more related to that than to a vaccine reaction (and he did it before this latest vaccine). The next day he was still fussy, but no longer inconsolable and no more high-pitched cry.   Note that mom reports baby had "dime to quarter sized hives" on his torso and knees, 4 days after his 4 month immunizations (Pentacel, Prevnar) on 4/7/15, but they resolved quickly and he had no fever.  He was also reported to be "fussy" after his DTaP on 6/10/15, but he had no other reactions.
Age: 0.53
Sex: M
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: 7 hours after patient received HIB vaccine, he woke up and was "inconsolable". He was arching his back and had a high-pitched cry. Mom stated "I have never heard a child have that type of cry."  The crying lasted for 1 hour (from 11pm until midnight). Then he went back to sleep.  Parents had given him Ibuprofen at around 8:30pm. Mom is concerned that patient arches his back a lot. He has GE reflux so I feel the back arching is more related to that than to a vaccine reaction (and he did it before this latest vaccine). The next day he was still fussy, but no longer inconsolable and no more high-pitched cry.   Note that mom reports baby had "dime to quarter sized hives" on his torso and knees, 4 days after his 4 month immunizations (Pentacel, Prevnar) on 4/7/15, but they resolved quickly and he had no fever.  He was also reported to be "fussy" after his DTaP on 6/10/15, but he had no other reactions.
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report as received from a Nurse Practitioner refers to a female patient of unknown age. On 11-DEC-2014, the patient was vaccinated with a dose of  VARIVAX (Merck) while she was pregnant (dosage, route, lot # not provided). Patient's last menstrual period (LMP) was in 2014 and the estimated date of delivery (EDD) was in 2015 (exact dates unknown). On an unknown date, in December 2014, the patient miscarried, while she was approximately 8 to 12 weeks pregnant (I trimester). The patient sought unspecified medical attention. The outcome of pregnancy was reported as abortion spontaneous. Foetus demographics and outcome were unknown. The outcome of miscarriage was unknown. Relatedness between the event of VARIVAX (Merck) was not specified. Upon internal review, the event of miscarriage was considered to be medically significant. Additional information is not expected as there was no consent to contact physician.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized erythema right upper outer arm within 6 hours of MENVEO injection with noticeable swelling, warmth, increased redness over next 24 hours. No fever, chills, facial swelling, cough, respiratory distress.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hot flush, Local reaction, Pain, Swelling
Clinical narrative: Local injection reaction swelling soreness (vaccine given IM) redness, swelling to about 1/2 egg, hot/flush, painful happened about 1 day after and lasting to 1 week after. Possible IM tear. Lasted for over 1 week.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Visit of 6/11/15->pt c/o itchy/rash. Area warm to touch, bigger in size than on vaccination date of 8 x 10 c,. ? Cellulitis vs local rx.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Ecchymosis, Skin discolouration, Swelling, Tenderness
Clinical narrative: Blue-red discoloration, ecchymosis, approx. 3 in. in diameter. Swelling and tenderness present.
Age: 8.0
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Significant erythema, swelling, pruritis, and lingering induration at injection site. Affected area approximately 20 cm x 15 cm-entire thigh to groin crease. Symptoms worsened over four days and then began to abate. Treatment was BENADRYL 12.5 mg PO Q.I.D. x 5. Temp: 99.6.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified patient of an unknown age and unknown gender. On an unknown date in 2015 (reported as past week), the unspecified patients were vaccinated with improperly GARDASIL (Lot# K007828 and expiry date:02-MAR-2017) (dose, frequency and route were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of an unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (dose, route of administration, lot# and expiration date were not reported). Concomitant medication 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.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 09-JUN-2015, the patient was administered with improperly stored dose of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX dose and route of administration were not reported (lot # K010337, expiry date 22-JUL-2016). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's current conditions and medical history were not reported. On 12-JUN-2015, the patient was inadvertently vaccinated with PROQUAD (Merck) (Lot # L006388 and expiry date of 25-AUG-2016) (unknown strength, route and dose) instead of prescribed M-M-R II. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of an unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot# reported as 1005292, expiration date reported as "08/17/201" dose and route of administration were not specified). Concomitant medication 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.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therpay with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality issue reported. This is one of the many reports form the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-MAY-2015 the patient was vaccinated with a dose of PROQUAD (Merck), lot # L003221, expiration date 30-JUL-2016 (dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Blister, Erythema
Clinical narrative: Large 14 x 14 area of erythema with blistering. BACTRIM DS given/prednisone given.
Age: 33.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Within 24 hours of vaccine pt developed 3 cm x 4 cm erythematous mildly swollen area below varicella vaccine site. Pt states today 6/18/15 that has egg allergy but pt. answered no to this on vaccine questionnaire yesterday. Treatment - oral ZYRTEC and hydrocortisone.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 02-JUN-2015, the patient was administered with improperly stored doses of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. On unspecified dates, the patients was vaccinated with improperly stored GARDASIL lot # K006960 and expiry date of 19-FEB-2017 (unknown strength, route and anatomical location). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients. No information on their medical histories, concurrent conditions and concomitant therapies was provided. On an unknown date, the patients received doses of improperly stored (Oka/Merck) VARIVAX lot # K008823 (expiration date reported as 19-JUN-2016), lot # K021487 (expiration date reported as 03-NOV-2016) and lot # L002870 (expiration date reported as 27-JAN-2017) (doses, routes and sites of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015 the patient was vaccinated with a dose of PROQUAD (Merck), lot # L003221, expiration date 30-JUL-2016 (dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown demographics. No pertinent medical history, concurrent conditions or concurrent conditions were reported. On an unknown date in MAY 2015, the patient was vaccinated with an expired dose of PNEUMOVAX, (lot number was unknown, expiration date was reported as an unspecified date in March 2015), via subcutaneous route. There were no known adverse effects reported. The outcome of expired product administered was unknown. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Local reaction
Clinical narrative: 8 x 10 cm localized reaction.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Shaking out of control. Fever. Chills. Sweating.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 27-MAY-2015, the patient was vaccinated with improperly stored MMR II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified patients of an unknown age and unknown gender. On an unknown dates in 2015 (reported as past week), the unspecified patients were vaccinated with improperly stored, oral, ROTATEQ (Lot# K012432 and expiry date: 20-MAY-2016) (dose and frequency were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 04-JUN-2015, the patient was vaccinated with improperly stored GARDASIL (route of administration and dose were not reported) (lot # K023432, expiry date: 18-JUN-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients received doses of ROTATEQ orally, that were improperly stored (strength, lot number, expiration date and dose # were not reported). There was no concomitant medication reported. No adverse experiences were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blindness unilateral, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 59 year old female patient concerning herself who had drug reaction/allergy to PERCODAN and had no medical history. On 16-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose number, route and duration were unspecified). Concomitant therapies included lisinopril (manufacturer unknown), lithium, NEXIUM and ZOLOFT. On 17-JAN-2015, the patient experienced a hot, red, swelled up, ache at the injection site after receiving ZOSTAVAX. Her physician stated that she had a full allergic reaction to the vaccine. Afterward (unspecified date in 2015) she lost vision in her left eye and developed joint pain in her shoulder and elbows. The patient had sought medical attention via office visit. No treatment was given for the events. The outcome of the events was reported as not recovered. Upon internal review, lost vision in the left eye was considered to be medically significant. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 59 year old female patient concerning herself who had drug reaction/allergy to PERCODAN and had no medical history. On 16-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose number, route and duration were unspecified). Concomitant therapies included lisinopril (manufacturer unknown), lithium, NEXIUM and ZOLOFT. On 17-JAN-2015, the patient experienced a hot, red, swelled up, ache at the injection site after receiving ZOSTAVAX. Her physician stated that she had a full allergic reaction to the vaccine. Afterward (unspecified date in 2015) she lost vision in her left eye and developed joint pain in her shoulder and elbows. The patient had sought medical attention via office visit. No treatment was given for the events. The outcome of the events was reported as not recovered. Upon internal review, lost vision in the left eye was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified patients of an unknown age and unknown gender. On an unknown dates in 2015 (reported as past week), the unspecified patients were vaccinated with improperly stored LIQUID PEDVAXHIB (Lot# K008877, expiry date: 24-FEB-2017 and Lot# K019700, expiry date: 16-JUL-2017) (dose, frequency and route were not reported). No adverse effects were reported. No product quality complaint (PQC) was reported for LIQUID PEDVAXHIB. This is one of the several reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Joint range of motion decreased, Localised oedema
Clinical narrative: This spontaneous report was received from a health care professional refers to 3 or 4 patients of unknown demographics. On an unknown date the patients were vaccinated with PNEUMOVAX 23 injection (dose, route, frequency and lot # unspecified). Concomitant therapy was not reported. On an unknown date, patient experienced extreme pain that was debilitating and achiness described as had decrease range of motion in the shoulder joint of the upper arm area. Nurse reported the pain was localized to the general area in the shoulder joint of the upper arm. Nurse reported she rated the pain as a 10 out of 10. Nurse reported patients also had localized edema in an unspecified location. Nurse also reported that these 3 or 4 other patients who experienced the same symptoms as the related case patient after taking PNEUMOVAX 23. Patient sought medical attention and spoke to nurse. The outcome of joint range of motion decreased, asthenia, localised oedema and musculoskeletal pain was unknown. Causality assessment was not reported. This case is linked to: 1506USA003505 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician Assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that on 19-AUG-2014, 01-OCT-2014, 03-NOV-2014, 14-NOV-2014, 29-DEC-2014, 14-JAN-2015 and 10-MAR-2015, the patients received doses that were improperly stored VAQTA (strength, lot number, expiration date, dose # and route of administration were not reported). There was not concomitant medication reported. No adverse experiences were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with improperly stored doses of PROQUAD (Merck) dose and route of administration were not reported (lot # K020753, expiry date 30-APR-2016). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: 6-11-15 Red, itchy arm (Rt).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Baseball like reaction at administration site and got chicken pox on hand from ZOSTAVAX vaccine.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Localized swelling of left arm 8 hours after injection. Given DEPO MEDROL 80mg injection on 6/19/15.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Dermatitis, Hyperaesthesia, Injection site pain, Pyrexia
Clinical narrative: Soreness at inj. site. Skin inflammation / burning migrated down inner arm approx. 1 in., elbow tenderness x12 h. Inflammation / skin sensitivity x1 week. Low-grade fever x72 hr.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Soreness at inj. site. Skin inflammation / burning migrated down inner arm approx. 1 in., elbow tenderness x12 h. Inflammation / skin sensitivity x1 week. Low-grade fever x72 hr.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and the slight swelling at the site of injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Swelling
Clinical narrative: Pt. received (L) deltoid IM vaccine (PPSV23) on 5/14/15. She called on 5/27 to report swelling and pain and limited ROM. She was advised heat / ice / NSAID's and had f/u appt. on 6/5/15. At appt. (L) arm symptoms completely resolved. She c/o new onset (R) arm symptoms. ((R) arm symptoms persist but ? related to vaccine).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Pt complaining of reaction at site of injection. Red, rash, swollen. Itching at site as well as up through neck area. Pt feeling feverish.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Pt complaining of reaction at site of injection. Red, rash, swollen. Itching at site as well as up through neck area. Pt feeling feverish.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: + "seizue" fever 101-103 F on 6-17-15 at about 9 am (24 hours after vaccination). DTAP, HIB, PREVNAR given 6-16-15.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Skin reaction
Clinical narrative: Local skin reaction. Swelling redness of injection site left arm.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling of injection site.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 46 year old female patient. Concurrent conditions and medical history were not specified. On 11-JUN-2015, the patient was vaccinated with 0.5 ml of PNEUMOVAX 23 (intramuscular injection) lot#K007826. Later that same day, the patient developed cellulitis just below the injection site. Concomitant therapies included LIPITOR, PRINIVIL and metformin. The patient was seen in the physician's office on 12-JUN-2015 and was prescribed an unspecified antibiotic to treat the cellulitis. There was no intervention to prevent serious criteria and no labs were performed. The event was considered to be not cancer, overdose or life threatening. There was no significant disability, incapacity, hospitalization or prolongation. PQC was not involved. The outcome of the and the relatedness with PNEUMOVAX 23 were not reported. This case is one of two cases from the same reporter (MARRS#506USA009646). Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a healthcare student concerning an approximately 42 year old female patient. It was reported that the patient never had chickenpox but experienced outbreaks of shingles "every few months" since an unspecified date. The patient had no drugs reactions or allergies. "About 5 years ago, maybe longer" in approximately 2010, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not provided) at an age younger than 50 years old, with the intent of stopping the shingles outbreaks. However patient continued to develop outbreaks of shingles "every few months" since an unspecified date after receiving ZOSTAVAX. The patient was given acyclovir (manufacturer unknown) as treatment for the shingles outbreaks. It was reported that patient had "just gotten over" her most recent outbreak (unspecified date). The patient sought medical attention by visiting her physician. Additional information is not expected because there is no consent for follow up.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Blood culture, Culture urine, Full blood count, Pyrexia
Clinical narrative: Fever 103, abd pain, vomiting lasting from 6/12/15 through 6/18/15. Shots given 6/10/15.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Streptococcus test, Urine analysis, Vomiting
Clinical narrative: Fever 103, abd pain, vomiting lasting from 6/12/15 through 6/18/15. Shots given 6/10/15.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored PNEUMOVAX 23, (dose and route were not reported), lot # K007826 expiration date 03-FEB-2016 and other lot # was reported as K016153 expiration date 24-SEP-2016. No adverse effects were reported. The patient's concomitant therapies were not reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an infant patient of unknown age and gender. Concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (2.5mcg/0.5 ml) (route not reported). Concomitant therapy was not reported. On an unknown date (reported as now) the patient showed negative antibodies for hepatitis B (blood test) and would be revaccinated. PQC was not involved. The outcome of the event was reported as not recovered/not resolved. The relatedness of the event with RECOMBIVAX HB was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot #, strength, route of administration and dose were not provided). No adverse experiences 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.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL, (dose and route were not reported), lot # K007828 expiration date 02-MAR-2017. No adverse effects were reported. The patient's concomitant therapies were not reported. This is one or two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Pharmacist Doctor refers to a patient of unknown age and gender. Concurrent conditions and medical history was not reported. On an unknown date, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 (dose and route not reported) Lot # K004148 with an expiration date of 10-MAY-2015. Concomitant therapy was not reported. No adverse effects reported. No PQC involved. Additional information has been requested.