chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Pyrexia, Screaming, Tremor
Clinical narrative: Reaction/Event: developed fever as high as 101.3F. Case Narrative: Upon second medical examination of the case at the time of internal review changed has been done in subject screen, product screen and removed event "irritability" and updated Core Unlisted for screaming in event screen. Changed has been completed in assessment screen and company narrative as per instructions. Initial unsolicited report received from a non-healthcare professional (patient's parent) on 8 October 2015. This case involves a (2-month-old) male patient who was vaccinated with a [route and dose series not reported] dose of ACTHIB (batch number UI376AA, expiry date and site of administration were not reported), received a dose of PEDIARIX (manufacturer GSK , batch number, expiry date and site of administration were not reported), received a dose of PREVNAR (manufacturer PFIZER , batch number, expiry date and site of administration were not reported) and also received a dose of ROTAVIRUS VACCINE (manufacturer other , batch number, expiry date and site of administration were not reported) all vaccines administered on 7 October 2015 (10:00 AM). Patient did not have illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications was not reported. On 7 October 2015, patient had developed fever as high as 101.3 Fahrenheit. It was reported that, patient continues to run fever 24 hours later and had shakiness and screaming. Laboratory investigation and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none. Addendum: 07 Jan 2016, Upon second medical examination of the case at the time of internal review changed has been done in subject screen, product screen and removed event "irritability" and updated Core Unlisted for screaming in event screen. Changed has been completed in assessment screen and company narrative as per instructions.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Audiogram abnormal, Blood test, Deafness unilateral, Decreased appetite
Clinical narrative: Sick for two weeks. Severe, constant whole body pain with hot stabbing pain in right LE. Constant headache. Fever, sweating, nausea, loss of appetite, weight loss, vertigo, dizziness, weakness, loss in of hearing in right ear (need hearing aids now - both ears), painful sores & scabs inside nose and all over tongue (ongoing), painful fissures on tongue (ongoing).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Malaise, Mucosal inflammation
Clinical narrative: Sick for two weeks. Severe, constant whole body pain with hot stabbing pain in right LE. Constant headache. Fever, sweating, nausea, loss of appetite, weight loss, vertigo, dizziness, weakness, loss in of hearing in right ear (need hearing aids now - both ears), painful sores & scabs inside nose and all over tongue (ongoing), painful fissures on tongue (ongoing).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging brain, Pain, Pain in extremity, Plicated tongue
Clinical narrative: Sick for two weeks. Severe, constant whole body pain with hot stabbing pain in right LE. Constant headache. Fever, sweating, nausea, loss of appetite, weight loss, vertigo, dizziness, weakness, loss in of hearing in right ear (need hearing aids now - both ears), painful sores & scabs inside nose and all over tongue (ongoing), painful fissures on tongue (ongoing).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Scab, Tongue ulceration, Vertigo, Weight decreased
Clinical narrative: Sick for two weeks. Severe, constant whole body pain with hot stabbing pain in right LE. Constant headache. Fever, sweating, nausea, loss of appetite, weight loss, vertigo, dizziness, weakness, loss in of hearing in right ear (need hearing aids now - both ears), painful sores & scabs inside nose and all over tongue (ongoing), painful fissures on tongue (ongoing).
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large red indurated area at site of injection.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Bronchitis, Chest X-ray, Nasopharyngitis, Productive cough
Clinical narrative: Increased phlegm, cold like symptoms that gradually worsened, Bronchitis diagnosed today (03/02/2016), x-ray to r/o pneumonia.  Patient requested it be reported today.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: Was given shot on upper left arm.  Since then, I have had pain in upper arm around bicep/tricep shoulder area.
Sex: U
Vaccine: HEPA
Symptoms: Multiple sclerosis
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple sclerosis in a adolescent subject who received Hepatitis A. Co-suspect products included sodium chloride for an unknown indication. On an unknown date, 183 days after receiving Hepatitis A vaccine, the subject developed multiple sclerosis. Serious criteria included GSK medically significant. The outcome of multiple sclerosis was unknown. The investigator considered that there was a reasonable possibility that the multiple sclerosis may have been caused by Hepatitis A vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of sclerosis multiple in patient of unspecified gender at least 10 years old and less than 26 year old who had received HAVRIX. The patient received the vaccines as part of a clinical trial with the following inclusion criteria: availability for the entire study period and using a highly effective contraceptive method during the study if sexually active. In addition to this, it had the following exclusion criteria: previous meningococcal B or hepatitis A vaccine, any contraindication for hepatitis A vaccination, scheduled to receive at least one dose of human papillomavirus vaccine between visit 1 and 28 days after vaccination 2, previous anaphylactic reaction to any vaccine or vaccine-related component, history of microbiologically proven disease caused by N. meningitidis or N. gonorrhea, current pregnancy or breastfeeding. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received 2 doses of HAVRIX following a 0 and 6 months schedule. Dosage: either 720 ELISA units or 1440 ELISA units of viral antigen per 0.5mL or 1.0mL dose (age specific doses according to country specific guidelines). Administration route: intramuscular using a 25gauge, 1inch needle; site was upper deltoid muscle with a 25gauge, 1inch needle. Batch numbers were not provided. In addition to this, the patient was administered 0.5mL normal sterile saline solution for injection (0.9% sodium chloride) as placebo at month 2. On an unspecified date, within 6 months of the second vaccine, the patient was diagnosed with multiple sclerosis. Treatment was unknown. Outcome was unspecified at the time of reporting. The authors commented that this had been considered by the investigator as related to study vaccination. The authors concluded that the "the results presented provide additional data demonstrating that bivalent rLP2086 has an acceptable safety and tolerability profile in healthy individuals greater or equal to 10 to 26 years of age. No new safety concerns were identified in this trial of a vaccine that is important for the prevention of a severe disease".
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site exfoliation, Injection site pain, Injection site pruritus
Clinical narrative: Redness, pair, pruritus at injection site. Left upper arm erythematous, scaling, skin intact. No drainage. Dispensed hydrocortisone 1% cream and TYLENOL for pain.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient had syncopal episode approximately 2 minutes after HPV vaccine injection, lasting approximately 15-20 seconds. Patient was sitting in a chair, no injury occurred. Patient regained consciousness immediately after ammonia inhalants were given. No ongoing effects noted.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Hallucination, Headache, Muscle spasms, Paraesthesia oral, Tinnitus
Clinical narrative: About 8 hours post vaccination she reports muscle spasms radiating from her shoulders to her chest, 12 hours after vaccine developed severe headache, and hives along the right side of her chest. Thirty six hours after vaccine she claims she had hallucinations during the night.  About 48 hours post vaccination states she had reports ringing in her ears. Six days post vaccination she claims she had tingling along the sides of her mouth.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: About 8 hours post vaccination she reports muscle spasms radiating from her shoulders to her chest, 12 hours after vaccine developed severe headache, and hives along the right side of her chest. Thirty six hours after vaccine she claims she had hallucinations during the night.  About 48 hours post vaccination states she had reports ringing in her ears. Six days post vaccination she claims she had tingling along the sides of her mouth.
Age: 0.32
Sex: M
Vaccine: DTAP, HIBV, RVX
Symptoms: Crying, Diet refusal, Pyrexia
Clinical narrative: Cry inconsolably for 3 days. Not wanting to eat for 3 days. Fever 101.9 for 3 days on and off with Motrin.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Autopsy, Death
Clinical narrative: Pt was found deceased in bed by parent.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Abasia, Activities of daily living impaired, Asthenia, Dysstasia, Immediate post-injection reaction
Clinical narrative: 01/27/2015 9:30am 0.5 mL MMR Lot # k003806 vaccination administered in Upper Left Leg using 25G x 5/8" Jelco Hypodermic Needle. Grandmother 30 year veteran nurse present as patient's guardian on that day has administered many shots in her career. Stated shock at witnessing how the shot was administered 'very roughly'. Patient experienced immediate extreme leg pain at the point where the shot was administered. Doctor was phoned within a few days to request advice regards pain. Doctor stated pain was normal and would subside in few days to weeks. Leg pain continued at the area of the shot without resolution. Patient taken to see Doctor one month to six weeks later, extreme pain still present causing patient immobility. Dr. prescribed therapy. Therapy course completed, minimal to no improvement. Through the duration of aprox one year pain continues to arise particularly after moderate activity, patient is unable to walk or even stand due to extreme pain starting at the point of the shot and radiating through her leg. Doctor Visit Jan 19th, 2015 discussed continuing pain from vaccination. Was advised to file VAERS report. In contradiction to the clear onset of symptoms tracing their direct roots to the moment of administration of vaccination the Doctor advised to follow a course of testing to determine if some underlying systemic pre-existing condition existed that never manifested itself previously even though patient had multiple previous vaccinations and other normal childhood injuries that never resulted in any long term symptoms such as she has experienced directly upon adminstration of the MMR vaccination. To explore another route beside the highly unlikely idea of a possible pre-existing condition diagnosis Doctor consulted a Rheumatologist who advised an X-ray be taken to examine the possibility of injury due to trauma from the injection. X-ray results for Myositis ossificans were negative. As of the day of this report patient continues to experience debilitating leg pain on a regular basis causing her to have to refrain from anything more than minimum physical activities. She is unable to make it through a day of normal childhood activities, nor participate in sports, nor even bike a few blocks to school without experiencing pain at the spot of the vaccination that makes her have to stop all activity for at least a day before she can walk again.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: 01/27/2015 9:30am 0.5 mL MMR Lot # k003806 vaccination administered in Upper Left Leg using 25G x 5/8" Jelco Hypodermic Needle. Grandmother 30 year veteran nurse present as patient's guardian on that day has administered many shots in her career. Stated shock at witnessing how the shot was administered 'very roughly'. Patient experienced immediate extreme leg pain at the point where the shot was administered. Doctor was phoned within a few days to request advice regards pain. Doctor stated pain was normal and would subside in few days to weeks. Leg pain continued at the area of the shot without resolution. Patient taken to see Doctor one month to six weeks later, extreme pain still present causing patient immobility. Dr. prescribed therapy. Therapy course completed, minimal to no improvement. Through the duration of aprox one year pain continues to arise particularly after moderate activity, patient is unable to walk or even stand due to extreme pain starting at the point of the shot and radiating through her leg. Doctor Visit Jan 19th, 2015 discussed continuing pain from vaccination. Was advised to file VAERS report. In contradiction to the clear onset of symptoms tracing their direct roots to the moment of administration of vaccination the Doctor advised to follow a course of testing to determine if some underlying systemic pre-existing condition existed that never manifested itself previously even though patient had multiple previous vaccinations and other normal childhood injuries that never resulted in any long term symptoms such as she has experienced directly upon adminstration of the MMR vaccination. To explore another route beside the highly unlikely idea of a possible pre-existing condition diagnosis Doctor consulted a Rheumatologist who advised an X-ray be taken to examine the possibility of injury due to trauma from the injection. X-ray results for Myositis ossificans were negative. As of the day of this report patient continues to experience debilitating leg pain on a regular basis causing her to have to refrain from anything more than minimum physical activities. She is unable to make it through a day of normal childhood activities, nor participate in sports, nor even bike a few blocks to school without experiencing pain at the spot of the vaccination that makes her have to stop all activity for at least a day before she can walk again.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: (L) lateral arm - 10.8 x 7.5 cm erythematous area - with induration and warmth. Tender, no fluctuance - surrounding location of vaccination started 24 hrs after vaccination.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient described shoulder pain almost immediately after receiving the vaccine she continued to have pain and could not lift her arm. She had PF and then an MRI.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drooling, Loss of consciousness, Tremor
Clinical narrative: Patient received three vaccines then he lost consciousness, shaking and drooling.  He was sitting in the seat so I attempted to lower him to the floor and mom was holding him.  She yelled if we had smelling salt so as I cracked the ammonia salt patient had already started responding to mom.  Patient stated that he was scared of getting the shots.  Then he started to phase out again but mom yelled his name and he responded.  Oxygen started and MD notified.  Mom proceeded to inform me that this happens whenever he receives vaccines or has blood work done.  She states she forgot to let us know.  Informed her to let us know before the next vaccine so we can take him lay down for vaccines.  Oxygen saturation at 98-99% with and without the oxygen.  Pt asked for water.  Tolerated well.  Patient left walking.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness at injections site.  No itching or pain.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site bruising, Injection site pain, Pain in extremity
Clinical narrative: Injection site bruising, injection site pain, fatigue, left arm pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Injection site reaction, Neuralgia, Pain, Paraesthesia
Clinical narrative: Patient reported nerve pain (traveling from injection site down to hands on right arm 2-3 weeks after vaccine), numbness, tingling, soreness.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Central nervous system lesion, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia, Scan with contrast
Clinical narrative: Awoke with tingling from my breast down to my toes. Went to urgent care 01/11/2016 referred to neurologist and first of three MRIs. 01/14/2016 all fingertips except thumbs began to tingle. Found three lesions in spinal column and brain areas hyperintensities.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: White matter lesion
Clinical narrative: Awoke with tingling from my breast down to my toes. Went to urgent care 01/11/2016 referred to neurologist and first of three MRIs. 01/14/2016 all fingertips except thumbs began to tingle. Found three lesions in spinal column and brain areas hyperintensities.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Dyspnoea, Erythema, Injection site induration, Platelet count decreased, Pruritus
Clinical narrative: Received a call from patient's mom a few minutes after leaving the clinic. She stated that patient had difficulty of breathing while in the car and had started to c/o being itchy. She immediately turned around and went back to the clinic. While in the clinic, initial oxygen Sat was 95%, was very itchy with hives on the trunk, with facial erythema but no puffiness nor swelling of the lids nor lips. DUONEB given with resolution of DOB, O2 Sat post-neb was 100%. BENADRYL 7.5  ml and Prednisolone 10 ml PO were given. Facial erythema and hives initially got worse then completely resolved after approximately an hour post-ingestion. Area of MMRV injection was markedly indurated. Consulted Dr. regarding patient's reaction. Advised to repeat a CBC but unfortunately machine does not measure eosinophils (repeat showed decreased platelet from 138 to 88 but no epistaxis/active bleeding).Serum tryptase sent to outside lab. Home meds to include: ZYRTEC, BENADRYL RTC Q 6 hours, Prednisolone 2 mg/kg, Alb nebs prn and EPIPEN Jr. pack. Will schedule f/u with Dr tom. Has previously received Flu without incident, KINRIX and MMRV combination new for patient. KINRIX site of injection without any induration. Patient was discharged home stable with instructions on what to do if hives recur and go to ER for any red flags.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Tryptase, Urticaria
Clinical narrative: Received a call from patient's mom a few minutes after leaving the clinic. She stated that patient had difficulty of breathing while in the car and had started to c/o being itchy. She immediately turned around and went back to the clinic. While in the clinic, initial oxygen Sat was 95%, was very itchy with hives on the trunk, with facial erythema but no puffiness nor swelling of the lids nor lips. DUONEB given with resolution of DOB, O2 Sat post-neb was 100%. BENADRYL 7.5  ml and Prednisolone 10 ml PO were given. Facial erythema and hives initially got worse then completely resolved after approximately an hour post-ingestion. Area of MMRV injection was markedly indurated. Consulted Dr. regarding patient's reaction. Advised to repeat a CBC but unfortunately machine does not measure eosinophils (repeat showed decreased platelet from 138 to 88 but no epistaxis/active bleeding).Serum tryptase sent to outside lab. Home meds to include: ZYRTEC, BENADRYL RTC Q 6 hours, Prednisolone 2 mg/kg, Alb nebs prn and EPIPEN Jr. pack. Will schedule f/u with Dr tom. Has previously received Flu without incident, KINRIX and MMRV combination new for patient. KINRIX site of injection without any induration. Patient was discharged home stable with instructions on what to do if hives recur and go to ER for any red flags.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Immediate post-injection reaction, Insomnia, Musculoskeletal stiffness, Pain
Clinical narrative: When given the injection, I immediately had pain go down my arm for a few seconds and subsided quickly. By that afternoon my entire upper arm ached. I had pain in my arm that was severe when I raised my arm or adducted my arm. I took ADVIL. I could not sleep due to the pain and my shoulder was stiff in the evenings. I increased to taking 2 ADVIL at bedtime and changed my position for sleeping which helped slightly. I did not feel it was getting any better so on 11/30/2015 I went to the doctor. I was told it was not from the shot (why did it start with the shot?). I was told I had arthritis and a frozen shoulder and given exercises to do. I had an X-ray on 12/1/2015 to check for arthritis. I tried the exercises on 12/1/2015 - doing the exercises did not hurt but the pain in my upper arm became very intense after an hour and later that day, pain shot down my arm again. I stopped doing the exercises. I continued taking ADVIL and avoided adducting my arm or raising it. I waited for the doctor's call about the X-ray which I never got. My arm gradually improved. By January I stopped taking the ADVIL. I still had pain with adduction - so I had pain occasionally when driving as I turn using a hand over hand method. Today in Feb. that pain is gone. I still have pain when dancing when my arm is raised and adducts while I turn. I also have a weakness in that arm when I get a gallon jug out of the refrigerator. I always get a yearly flu shot and never had problems before.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Periarthritis, X-ray limb normal
Clinical narrative: When given the injection, I immediately had pain go down my arm for a few seconds and subsided quickly. By that afternoon my entire upper arm ached. I had pain in my arm that was severe when I raised my arm or adducted my arm. I took ADVIL. I could not sleep due to the pain and my shoulder was stiff in the evenings. I increased to taking 2 ADVIL at bedtime and changed my position for sleeping which helped slightly. I did not feel it was getting any better so on 11/30/2015 I went to the doctor. I was told it was not from the shot (why did it start with the shot?). I was told I had arthritis and a frozen shoulder and given exercises to do. I had an X-ray on 12/1/2015 to check for arthritis. I tried the exercises on 12/1/2015 - doing the exercises did not hurt but the pain in my upper arm became very intense after an hour and later that day, pain shot down my arm again. I stopped doing the exercises. I continued taking ADVIL and avoided adducting my arm or raising it. I waited for the doctor's call about the X-ray which I never got. My arm gradually improved. By January I stopped taking the ADVIL. I still had pain with adduction - so I had pain occasionally when driving as I turn using a hand over hand method. Today in Feb. that pain is gone. I still have pain when dancing when my arm is raised and adducts while I turn. I also have a weakness in that arm when I get a gallon jug out of the refrigerator. I always get a yearly flu shot and never had problems before.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient had a twin. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 18-FEB-2016, the patient was vaccinated with an expired dose of MMR II injection, lot # reported as K00738, expiration date 16-JAN-2016 (strength, dose and route of administration were not provided. No adverse effects were reported. Lot number K00738 is an invalid lot number for MMR II. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 29-FEB-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L019297 with expired date 18-AUG-2017, dose and route were unknown). No concomitant medication was reported. The reporter stated that the vaccine was stored in 12 degrees Celsius for 6.5 hours and there was no previous temperature excursion. No adverse effect was reported. Additional information is not expected since the reporter refused further contact.
Age: 32.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 32-year-old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications were reported. On 24-FEB-2016, the patient was accidentally vaccinated with a dose of PROQUAD (Merck) subcutaneously (dose, lot #, expiry date and anatomical location were not specified). On the same date, the patient received also a dose of VARIVAX (Merck) subcutaneously (dose, lot #, expiry date and anatomical location were not reported). It was reported that the vaccines were administered in "different locations". No adverse effect was 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: Information has been received from a healthcare worker referring to multiple, unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL (dose and route not reported, lot # K010215 with expiration date 05-MAY-2017). No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1603USA000669). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple, unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with improperly stored (temperature: 32 F and time frame: 75 hours (5 cycles of 15 hours each)) doses of ROTATEQ (dose not reported, lot # L004466 with expiration date 02-AUG-2016 and lot # L013203 with expiration date 28-JAN-2017) orally. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1603USA000576). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse via filed representative referring to a patient of unknown age and gender. There was no medical history or drug reactions/allergies reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot# were unknown), followed by a dose of GARDASIL 9 (dose, route and lot# were unknown) in December 2015 (reported as "2 months before the third dose of GARDASIL 9"). On 26-FEB-2015, two months after the second dose, the third dose of GARDASIL 9 (dose, route and lot# were unknown) was vaccinated. No adverse effects were reported. 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 multiple unspecified patients of unknown age. On an unknown date the patient was vaccinated with doses of improperly stored (Merck) VARIVAX (unknown lot #s and expiration dates). The vaccine was stored under -8 degree Celsius for 8 hours and 33 minutes. No previous temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. 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 refers to multiple unspecified patients of unknown age. On an unknown date the patient was vaccinated with doses of improperly stored VAQTA (unknown lot #s and expiration dates). The vaccine was stored under 1.3 degree Celsius for 35 hours. No previous temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received 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 a physician refers to multiple unspecified patients of unknown age. On an unknown date the patient was vaccinated with doses of improperly stored ROTATEQ (unknown lot #s and expiration dates). The vaccine was stored under 1.3 degree Celsius for 35 hours. No previous temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received 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 certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 10-DEC-2015, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (lot # L004466, expiry date 02-AUG-2016, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age. On an unknown date the patient was vaccinated with doses of improperly stored RECOMBIVAX HB (unknown lot #s and expiration dates). The vaccine was stored under 1.3 degree Celsius for 35 hours. No previous temperature excursion. No adverse effect was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to approximately 121 patients of unknown age and gender, who on an unknown date were vaccinated with a doses of PNEUMOVAX 23 (lot # L013428, expiration date 03-FEB-2017) stored in an incorrect temperature. No adverse effects reported. Additional information is not expected, due to lack of consent to contact with the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 11-DEC-2015, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (lot # L004466, expiry date 02-AUG-2016, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 09-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L038669 with expired date 11-AUG-2017, dose and route were unknown). No concomitant medication was reported. The reporter stated that the vaccine was stored in 34 degrees Fahrenheit for 48 hours and there was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin irritation
Clinical narrative: Information has been received from a female adult concerning herself. Around 2008 to 2010, the patient was vaccinated with ZOSTAVAX (it was reported as "shingles vaccine"). In 2013 the patient experienced shingles and it was a mild case. The shingles was showed as small silver dollar size under one arm. It only bothered/irritated her for a couple days. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient had a twin. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 18-FEB-2016, the patient was vaccinated with an expired dose of MMR II injection, lot # reported as K00738, expiration date 16-JAN-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. Lot number  K00738 is an invalid lot number for MMR II. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: This spontaneous report as received from an unknown source, as a part of market research, refers to an unspecified number of immunocompromised patients of unknown age and gender. There was no information about the patients' concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). It was reported that on unknown dates, PNEUMOVAX 23 was not as effective for immunocompromised patients. These patients must also receive PREVNAR. It needed to be given first, then PNEUMOVAX 23 one year later. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as there were no contact details provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration ate January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's wife refers to a 46-year-old male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in September 2015, the 46-year-old patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported (reported as "shingles"). There were no adverse effect reported. Additional information is not expected as no contact details were provided.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16-year-old female patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 22-OCT-2015, the patient was vaccinated with the first dose of GARDASIL lot # K016966, expiry date 10-MAY-2017 (dose, route of administration and anatomical location were not specified). On 24-NOV-2015, the patient received the second dose of GARDASIL lot # K016966, expiry date 10-MAY-2017 (dose, route of administration and anatomical location were not reported). On 23-FEB-2016, the patient was vaccinated with the third dose of GARDASIL lot # K016966, expiry date 10-MAY-2017) (dose, route of administration and anatomical  location were not provided). The patient did not experience any adverse effects. Product  quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 13-JAN-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outsides of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-JAN-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route of administration), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site warmth, Rash erythematous
Clinical narrative: Red rash, horrible pain, and heat at site of injection.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash, horrible pain, and heat at site of injection.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema multiforme, Injection site rash, Injection site reaction, Pallor, Skin lesion
Clinical narrative: Received PREVNAR 2/9/16. In several days developed 4cm x 4cm rash at site, then widespread rash, including blanchable palm lesions, consistent with erythema multiforme. Improving slowly. Pt is a world traveler and has had yellow fever, typhoid, cholera vaccines within last 2 yrs. Last tet = 2006 and 2012.
Age: 1.3
Sex: F
Vaccine: MMRV
Symptoms: Ear infection, Herpes zoster, Skin lesion
Clinical narrative: Pt. received PROQUAD (varicella and MMR) vaccination on 2.1.16 at 15 month well child exam. While on office on 2.25.15 a shingles rash was noted to left lower back. Rash was noticed by mother 7 days after injected. To right outer thigh. Approx. 7 days later mother noticed rash to left lower back. Pt in office on 2.25.16 for ear infection when dr. noted lesions on left lower back.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 11 year old female patient. No medical history was reported. Approximately on 23-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date 09-AUG-2017. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 13 year old male patient. No medical history was reported. Approximately on 21-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date 09-AUG-2017. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to a 16 year old female patient. No medical history was reported. Approximately on 24-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was been received from a health care worker referring to an 18 year old female patient. No medical history was reported. Approximately on 23-DEC-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an 11 year old female patient. No medical history was reported. Approximately on 27-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an 11 year old male patient. No medical history was reported. Approximately on 22-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017. No adverse effect was reported. This is one of the several reports received 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 a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-FEB-2016, the patient was vaccinated with improperly stored oral ROTATEQ, 2ml, once (dose number was not provided) lot # L013206, expiry date 29-JAN-2017. No adverse effects were reported. Temperature excursion was noted as 57 Fahrenheit for 71 hours and 45 minutes, there was no previous temperature excursion. This is one of two reports received 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 healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 18-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received 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 a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-JAN-2016, the patient was vaccinated with improperly stored oral, ROTATEQ, 2ml, once (dose number was not provided) lot # L013206, expiry date 29-JAN-2017. No adverse effects were reported. Temperature excursion was noted at 57 Fahrenheit for 71 hours and 45 minutes, there was no previous temperature excursion. This is one of two reports receive from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately February 2016 (reported as "since 10-FEB-2016"), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # K021881 with expiration date: 30-JUL-2016; lot # L019835 with expiration date: 23-MAR-2017 and lot 3 L014420 with expiration date: 23-FEB-2017 (exact dose, dose number, route of administration and anatomical location were not reported). There were no concomitant medications provided. Administered doses of vaccines experienced temperature excursion of 48.7 degrees Fahrenheit for 30 minutes. There were no previous temperature excursion. There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 25-FEB-2016 the patient was vaccinated with expired third dose of RECOMBIVAX HB (dosing details were not reported) lot # K014697 expiry date 04-FEB-2016. The reporter did not specify dates of administration for the first and second doses of RECOMBIVAX HB. No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.