chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.59
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 7 months old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 19-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 8 weeks old infant, gender not reported. On 19-NOV-2014, the patient was vaccinated with ROTATEQ, lot # K009181, orally. It was reported that the administered vaccine was subject to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 05-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K010642, orally. It is was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.22
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 11 weeks old infant, gender not reported. On 04-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 04-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subject to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 6 months old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subject to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Pruritus
Clinical narrative: Patient states itching and noticed a nodule with redness at the injection site.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Insomnia, Lymphadenopathy, Pyrexia
Clinical narrative: Fever and leg pain on night of vaccination, difficulty sleeping at night two days after vaccination, Fever continues, Swelling of inguinal lymph glands about 7 days post vaccination, Fever of 100.0 on 03/26/15.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 9 week old patient, gender not reported. On 03-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K002991, orally. It was reported that the administered vaccine was subjected to temperature excursion. No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Abasia, Asthenia, Lumbar puncture, Mononucleosis heterophile test, Motor dysfunction
Clinical narrative: Tingling in hands 1 wk after; Day 10 after vaccine body aches, weakness, Day 14 she had inability to walk and total loss of motor control in hands.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Nerve conduction studies, Pain, Paraesthesia, Streptococcus test
Clinical narrative: Tingling in hands 1 wk after; Day 10 after vaccine body aches, weakness, Day 14 she had inability to walk and total loss of motor control in hands.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 8 weeks old infant, gender not reported. On 19-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K011663, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an unidentified caller and refers to a 9-month-old patient of unkonwn gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. The reporter stated that on an unknown date, the patient received a dose of ROTATEQ (dose, lot# and expiration date were not reported; route of administration defaulted to oral). No adverse effects were reported. Additional information is not expected, no contact details were provided.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 8 weeks old infant, gender not reported. On 19-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009161, orally. It was reported. that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.81
Sex: M
Vaccine: IPV
Symptoms: Abnormal behaviour, Cough, Eye discharge, Insomnia, Irritability
Clinical narrative: High temperature, behavioral changes, drowsiness, green runny nose, green goop in eyes, irritability, sleeplessness, cough.
Age: 0.81
Sex: M
Vaccine: IPV
Symptoms: Nasal mucosal discolouration, Pyrexia, Rhinorrhoea, Somnolence
Clinical narrative: High temperature, behavioral changes, drowsiness, green runny nose, green goop in eyes, irritability, sleeplessness, cough.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Haemoptysis, Influenza like illness, Oropharyngeal pain
Clinical narrative: ON 3/21/15 CLIENT STATED SHE HAD A SORE THROAT. ON 3/21/15 CLIENT STATED SHE NOTICED FLULIKE SYMPTOMS. 3/22/15 SYMPTOMS CONTINUE. 3/23/15 SPAT BLOOD STREAKED SPUTUM IN AM CLIENT STATED THIS HAPPENS WHENEVER SHE HAS A COLD THIS ALWAYS OCCURS. CLIENT STATED SHE WAS TOLD BY A DOCTOR THAT THIS WAS NORMAL. 3/24/15 SHE SPAT BLOOD AGAIN IN THE AFTERNOON. 3/25/15 CLIENT CALLED DOH AND WENT TO URGENT CARE AND STATED SHE WAS ADVISED THAT THESE SYMPTOMS MAY CONTINUE FOR A FEW FOR MORE DAYS.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed left arm pain and redness at site of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: 8 days after MMR, pt. diagnosed ITP platelet count=9.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: Pain at the site of the injection starting at the time of the injection and worsening throughout the day, with limitation of range of motion.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Chest discomfort, Pyrexia
Clinical narrative: Fever 102.6, possible seizure, "tight chest". Referred to physician.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Paraesthesia, Somnolence
Clinical narrative: Light headedness, dizziness, drowsiness. Tingling in fingers and toes on left/vaccinated side. All sxs lasted for about 1 hour.
Age: 0.32
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray normal, Dyspnoea, Hypotonia, Pallor, Respiratory syncytial virus test negative
Clinical narrative: Pale coloration to dusky coloration, irregular breathing, limp body. No fever prior to ER visit.
Age: 0.32
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Skin discolouration
Clinical narrative: Pale coloration to dusky coloration, irregular breathing, limp body. No fever prior to ER visit.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient states that he began feeling pain and stiffness in his right arm about 2 weeks after receiving the vaccine.  He saw his physician in December 2014, and reported the problem, but the doctor did not address the issue.  The patient states that his arm began getting weaker and more stiffness after this time, but with some increase in exercise of the muscles, seem to get somewhat better.  The patient reported to me on March 25, 2015 of this issue for the first time. The arm showed no outward signs of swelling or infection, but the patient states that the pain is persisting.  I advised the patient to return to the doctor for a full evaluation of the problem.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness around area of shot expanded and skin became itchy.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Huge knot on the left thigh with redness and heat and swelling.
Age: 19.0
Sex: F
Vaccine: FLU4, HEPA, HPV4, IPV, MEN, TYP, VARCEL, YF
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient given Menomune vaccine when she should have received Menactra. No adverse effect noted.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site nerve damage, Injection site reaction, Neuralgia
Clinical narrative: Sitting on couch, attempting to reposition myself, starting having horrible nerve pain in right upper arm where flu shot was given. Went to pcp next day and was dx with injection nerve injury. Was given a shot of cortisone in my shoulder and it was better for about 6 weeks then had to go back to doctor d/t increased pain. Was given a steroid taper this visit. Continue to have sporadic pain to area.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Following administration of Pneumovax to left arm, the arm began to swell with redness and tenderness which began within 24 hours of administration. Patient was scheduled to surgery so was given cephalexin prophylactically and reaction was watched closely for any changes.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Biopsy, Injection site discolouration, Injection site reaction, Laboratory test abnormal, Malignant melanoma in situ
Clinical narrative: Developed Melanoma of skin at site of previous Anthrax vaccine injections. I received the vaccine seven times in the right upper arm from 2004-2012. A flat pale tan 1.5 cm skin discoloration was noted at the site in Jan 2011. It was located in a site that I do not ordinarily see, but I had no history of birthmark at the site. The margins were regular at first. In May 2014, the skin mark appeared to be changing. The margins appeared speculated. An excisional biopsy was performed on 10/27/2014. The diagnosis of melanoma-in-situ was made. Re-excision occurred on 11/10/2014 for a positive margin. I am a physician as well and suspect a possible link to vaccine. I have received multiple vaccines over the years but the only one that I can recall in the lower aspect of the right upper arm was anthrax. Untreated melanoma is fatal. Fortunately, I have been treated and have no recurrence thus far.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Pathology test
Clinical narrative: Developed Melanoma of skin at site of previous Anthrax vaccine injections. I received the vaccine seven times in the right upper arm from 2004-2012. A flat pale tan 1.5 cm skin discoloration was noted at the site in Jan 2011. It was located in a site that I do not ordinarily see, but I had no history of birthmark at the site. The margins were regular at first. In May 2014, the skin mark appeared to be changing. The margins appeared speculated. An excisional biopsy was performed on 10/27/2014. The diagnosis of melanoma-in-situ was made. Re-excision occurred on 11/10/2014 for a positive margin. I am a physician as well and suspect a possible link to vaccine. I have received multiple vaccines over the years but the only one that I can recall in the lower aspect of the right upper arm was anthrax. Untreated melanoma is fatal. Fortunately, I have been treated and have no recurrence thus far.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Cardiac failure congestive, Cardiac output decreased, Catheterisation cardiac abnormal, Dyspnoea
Clinical narrative: Started getting winded when taking stairs.   Got really weak by December 2002.  Finally taken to Urgent Care...very low cardiac output.  Went to see Dr. soon and with intercath determined my output was 15%.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Exercise electrocardiogram, Low cardiac output syndrome
Clinical narrative: Started getting winded when taking stairs.   Got really weak by December 2002.  Finally taken to Urgent Care...very low cardiac output.  Went to see Dr. soon and with intercath determined my output was 15%.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Blood culture, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient received Prevnar vaccination about a week ago, then worsening right upper extremity pain, swelling, erythema, warmth over the right shoulder in the area where the vaccine was placed.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Induration, Joint range of motion decreased, Pain
Clinical narrative: Pain; Induration; Limited range of motion.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nerve damage, Pain
Clinical narrative: Patient received intramuscular flu shot injection on 11/2/14. She states she was in a lot of pain for about three weeks went to see her doctor. He said that hit a nerve and that is why it is still hurting. She has  since been prescribed pain pills, muscle relaxers, cortisone injection which none of them have helped. Doctor is now prescribing physical therapy for her arm.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt presents to Urgent Care with left arm edematous, taut, red and hot to touch. Pt states that is site of vaccine. No fever. Pt was treated by Urgent Care MD.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Injection-site erythema.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area was sore and the next morning area painful, swollen and red.
Age: 47.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Biopsy skin normal, Blood test normal, Urticaria
Clinical narrative: When I woke up in the morning, I discovered a lot of big hive welts on my stomach and right thigh. I saw my primary care physician at 9:30 AM that morning. She prescribed 30 tabs of 5 mg Levocetirzine & 14 tabs of 20 mg Prednisone. After taking the medication, the hive welts subsided. It continues to reoccur to this day but also occurring on the neck, back, shoulders, arms, behind the neck, buttocks, inner thigh, legs. After that initial doctors visit, I saw a dermatologist on 4 occasions. They performed a blood test and skin biopsy with negative results. I continue to take the Levocetirzine 5 mg to this day. I visited a doctor today 26 March 2015 who set up a future allergist specialist appointment.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of drug administration
Clinical narrative: Tdap given sub-q instead of IM.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Lethargy, Myalgia
Clinical narrative: Muscle pains, lethargy, lack of appetite, lack of energy, chills, slight fever at times.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Muscle pains, lethargy, lack of appetite, lack of energy, chills, slight fever at times.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Rash generalised
Clinical narrative: Viral syndrome, aching, fever, tachycardia, progressive red rash on upper legs bilaterally, spreading to abdomen and buttocks, spreading up sides to underarms, very painful.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Tachycardia, Viral infection
Clinical narrative: Viral syndrome, aching, fever, tachycardia, progressive red rash on upper legs bilaterally, spreading to abdomen and buttocks, spreading up sides to underarms, very painful.
Age: 12.0
Sex: M
Vaccine: MEN, VARCEL, MEN, VARCEL
Symptoms: Dizziness, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site urticaria
Clinical narrative: A large red, raised welt at the shot sight. 2 and 1/2 in. by 2 in. It feels hot to the touch. My child says he is dizzy and his arm feels numb.
Age: 12.0
Sex: M
Vaccine: MEN, VARCEL, MEN, VARCEL
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: A large red, raised welt at the shot sight. 2 and 1/2 in. by 2 in. It feels hot to the touch. My child says he is dizzy and his arm feels numb.
Age: 12.0
Sex: M
Vaccine: MEN, VARCEL, MEN, VARCEL
Symptoms: Injection site warmth
Clinical narrative: A large red, raised welt at the shot sight. 2 and 1/2 in. by 2 in. It feels hot to the touch. My child says he is dizzy and his arm feels numb.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received FLUARIX. Concurrent medical conditions included iodine allergy, drug allergy and penicillin allergy. On an unknown date, the patient received FLUARIX 1 ml. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced pain in arm. Rechallenge with FLUARIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to FLUARIX. See case US2015GSK020072 for tolerance to next flu vaccination.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3
Symptoms: Erythema, Headache, Myalgia, Nausea, Pruritus
Clinical narrative: Headache, myalgia, urticarial pruritus, nausea vomiting and swelling, erythema. Hydroxyzine 25 mg once.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3
Symptoms: Swelling, Urticaria, Vomiting
Clinical narrative: Headache, myalgia, urticarial pruritus, nausea vomiting and swelling, erythema. Hydroxyzine 25 mg once.
Age: 19.0
Sex: F
Vaccine: HEP, HPV4, IPV, MNQ, TDAP
Symptoms: Accidental overdose, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old patient of unknown gender. No concurrent conditions or medical history were provided. On 09-DEC-2014, the patient was vaccinated with an adult dose of RECOMBIVAX HB injection administered intramuscularly (strength, dose, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effect was reported. Follow up information has been received from a registered nurse on 11-MAR-2015 refers to a 19 year old female patient with no known allergies who on 09-DEC-2014 received first dose of RECOMBIVAX HB (lot # K011239, expiration date not reported) in the right arm, 1 mL instead of an 0.5 mL dose which was needed for their age of group (Off label use). On the same date on 09-DEC-2014 the patient also received the following vaccines: first dose of GARDASIL (lot # K006191, expiration date not reported) (dose not reported), intramuscular in the left arm; first dose of ADACEL (lot # U5013AA, expiration date not reported) (dose not reported), intramuscular in the right arm; fourth dose of (Vero) IPOL (lot # K1169, expiration date not reported) (dose not reported) subcutaneous in the right arm and first dose of MENVEO (lot # A13051) (dose not reported), intramuscular in the left arm. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema, Skin warm
Clinical narrative: Very large area of mild edema, erythema, and heat of the posterior right arm.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Laboratory test, VIIth nerve paralysis
Clinical narrative: Bells Palsy-seen at ER thinking having stroke-strike protocol tests performed. Still receiving weekly PT-not completely resolved.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, X-ray
Clinical narrative: Within 2-3 hours of vaccination, patient was unable to lift arm. Pain has continued thru March 2015 despite course of physical therapy.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt came in after few months states when she got shot her arm swelled and was painful. Also, she now is experiencing pain from the arm to neck. At time (and few weeks after could not lift weeks).
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Granulocyte percentage, Haematocrit increased, Haemoglobin normal, Lymphocyte percentage
Clinical narrative: Patient received Immunizations Hep A and Influenza QUADRIVALENT 3/03/2015 and developed erythema 3-19-2015.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Platelet count normal, Streptococcus test negative, White blood cell count normal
Clinical narrative: Patient received Immunizations Hep A and Influenza QUADRIVALENT 3/03/2015 and developed erythema 3-19-2015.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with an unspecified number of improperly stored dose of ROTATEQ (lot number, dose were unknown) orally. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Sore arm, says she needs physical therapy, says shot given too high.
Age: 11.0
Sex: M
Vaccine: HPV4, MMR, TTOX
Symptoms: Loss of consciousness, Pallor, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old male patient. The patient's medical history was not reported. On 25-FEB-2015, the patient was in the physicians's office to receive M-M-R II (albumin status not provided), GARDASIL and unspecified tetanus toxoid vaccine (lot #, dose, route and site of administration were not provided for all the vaccines). The patient received 2 out of the 3 vaccines during the visit. The nurse administering the vaccines informed that the patient received M-M-R II and tetanus toxoid vaccine. On 25-FEB-2015, after administration of the 2 vaccines, the patient's face became pale white and he passed out. When the patient regained consciousness, he vomited. No medical treatment was given for the adverse events. The outcome of loss of consciousness, vomiting and pallor was unknown. The relatedness between the events and M-M-R II and GARDASIL was not reported. Additional information has been requested.
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Malaise, Mood altered, Viral infection
Clinical narrative: This case was reported by a consumer and described the occurrence of mood change in a infant male patient who received Dtpa vaccine. Previously administered products included DTaP vaccine (1st dose at 2 months and 2nd dose at 4 months of age.). On an unknown date, the patient received the 3rd dose of Dtpa vaccine. On an unknown date, less than a day after receiving dtpa vaccine, the patient experienced mood change, irritability, sickness and viral infection. On an unknown date, the outcome of the mood change, irritability, sickness and viral infection were recovered/resolved. It was unknown if the reporter considered the mood change, irritability, sickness and viral infection to be related to dtpa vaccine. Additional information was provided: This case has been reported by a consumer via a physician via another manufacturer. The consumer reported that her son received the 3rd of Dtpa vaccine at unspecified age and that in the evening, he experienced a change of mood, got sick, was irritable and had a viral infection. The patient recovered within a few days. No further information was provided.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: C-reactive protein, Erythema, Metabolic function test abnormal, Pain, Pyrexia
Clinical narrative: Fever, generalized aches, plus localized pain, redness, swelling.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Fever, generalized aches, plus localized pain, redness, swelling.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated "early" with the third dose of GARDASIL 0.5 ml, intramuscularly (lot number and expiry date were not reported). The reporter was not sure whether the dose in question was GARDASIL or GARDASIL 9. There was no concomitant medication provided. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Right thigh (vastus lateralis) with erythema and swelling from top of knee to lateral thigh greater than or equal to 4 inches. Had fever w/ temp to 102 degrees - 24 hours after immunization. DTaP and Hepatitis A vaccine administered greater than or equal to 1 in apart on RVL - fever and local redness began 24 hours after immunization.
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 61 year old female patient who on an unknown date, was vaccinated with an unspecified dose of M-M-R II (lot # not reported). On an unknown date, the patient received an additional dose (unspecified dose) of M-M-R II after child birth on an unspecified date. This was due to the patient experienced an antibody test abnormal (reported as "could not keep up resistance after child was born"). The outcome of antibody test abnormal was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to 28 patients of unknown demographics. On 24-MAR-2015 all the patients were vaccinated with improperly stored ZOSTAVAX. No adverse effects were reported at this time. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Pyrexia, Rash papular
Clinical narrative: Fever to 101.8 degrees x 2 days post vaccination. On the morining of day 3 small red, papular rash began at vaccine administration site and progressively spread to other areas of the body.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 15 year old patient, gender not reported. On 11-NOV-2014, the patient was vaccinated with GARDASIL, Lot # K004204, dose unspecified. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several 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 was received from a registered nurse concerning unspecified number of patients (demographics unknown). On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # not provided). The doses of VARIVAX (Merck) were exposed to -5.1C for 3 hours and 21 minutes. No adverse effects were reported. 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 registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were inadvertently administered with unknown number of doses of improperly stored PNEUMOVAX23 (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Decreased appetite, Headache, Injection site inflammation, Injection site warmth
Clinical narrative: Injection site became hot and inflammed. Patient experienced severe joint pain and headache. The joint pain lasted 2 days. The patient also had a loss of appetite. Symptom resolved after a few days.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 11 year old patient, gender not reported. On 12-NOV-2014, the patient was vaccinated with GARDASIL, Lot # K004204, expiry 12-JAN-2017, dose unspecified. It was reported that the administered vaccine was subject to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Acoustic stimulation tests, Autism
Clinical narrative: This spontaneous report as received from a pharmacist refers to her son, a male patient of unknown age with eczema. The patient had no drug reactions or allergies. Approximately on 2013 (reported as: about a year and a half ago) the patient was vaccinated with M-M-R II (Albumin status HSA; route, dosage, dose number and lot number unknown). The pharmacist also stated that her son received a flu vaccine she "thinks" it was FLUZONE, manufacturer unspecified) on an unspecified date and he "may have" also received (Oka/Merck) VARIVAX (route, dosage, dose number and lot number unknown), on an unspecified date, but she is "not exactly sure about the (Oka/Merck) VARIVAX". On July 2014 the patient was diagnosed with autism by an unspecified pediatrician. The pharmacist also reported that the eczema his son had, prior to receiving M-M-R II had "gotten better since receiving the M-M-R II". The patient sought medical attention and received occupational therapy and "ABA" the rapy for the autism since an unspecified date. The pharmacist reported that her son had a hearing test on an unspecified date in August 2014. The outcome of autism was unknown. Additional information is not expected because there is no authorization to contact physician.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 16 year old patient, gender not reported. On 19-NOV-2014, the patient was vaccinated with GARDASIL, Lot # K004204, expiry 12-JAN-2017, dose unspecified. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to unspecified number of patients (maybe 17 or 18) of unknown demographics. Pertinent medical history and drug allergies of the patients were unspecified. On unspecified date between February and March 2015, all these patients received ZOSTAVAX, .65 ml once, subcutaneous. No concomitant medications were reported. These patients experienced redness (mild to moderate) and swelling at injection site. Some of the patients got a bump at site, not described as blister. Reporting pharmacist stated that the symptoms dissipated over time and there were no details on any treatment. Outcome of the events were recovering. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patient of unknown age and gender. On unknown dates the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot number, dose and route were unknown). No adverse events were reported. This is one of several reports from the same source. 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 Medical Assistant refers to a patient of unknown age and gender. On 05-DEC-2014, the patient was vaccinated with GARDASIL, Lot # K008335, expiry 23-JUN-2016, dose unspecified. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.22
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from licensed vocational nurse (LVN) refers to a 14 month old patient of unknown gender. No information regarding current condition, medical history or drug allergies were reported. Approximately on 20-MAR-2015 (also reported as today) the patient was vaccinated with VARIVAX (Merck) injection (strength, dose number and route was unknown) with lot # J002618 which was expired on 01-MAR-2015. No adverse effect was reported. The outcome of event was unknown. No further information was provided. Additional information is not expected.
Age: 45.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 45 year old patient of unknown gender. patient's concurrent conditions, concomitant medication and medical history were not provided. On 23-MAR-2015 the patient was inadvertently vaccinated with a first dose of M-M-R II (subcutaneous, lot # J002866, 0.5ml once) that had expired on 12-MAR-2015. No adverse effect was reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 17 month old patient of unknown gender. Information about patient's current condition or medical history was not reported. The nurse reported that the patient received the first dose of M-M-R II (lot# not reported, 0.5ml, subcutaneously), at 14 months of age, on 18-DEC-2014 and the second dose of M-M-R II (lot# not reported, 0.5ml, subcutaneously), at 17 months of age, on 23-MAR-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were inadvertently administered with unknown number of doses of improperly stored M-M-R II (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report has been received from an unknown reporter and refers to a patient of unknown age and gender. On 08-OCT-2014, the patient was vaccinated with M-M-R II which underwent temperature excursion (on an unspecified date). This is one of several reports from the same source. 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 registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unkonwn date the patients were inadvertently administered with unknown number of doses of improperly stored GARDASIL (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 23-DEC-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 12 year old patient, gender not reported. On 04-DEC-2014, the patient was vaccinated with GARDASIL, Lot # K008335, expiry 23-JUN-2016, dose unspecified. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Rash
Clinical narrative: This spontaneous report was received from a physician via Pfizer (2015074370) regarding a female patient of unknown age. There was no information on medical history and concurrent conditions. The physician reported that on an unknown date, the patient was vaccinated with PNEUMOVAX 23 (product details not reported). There was no information on concomitant medications. Approximately on an unknown date in 2008 (reported as 7 years ago), she had severe reaction following the vaccination with joint pains, rash and severe fatigue. The physician also enquired if a reaction to PNEUMOVAX23 was a contradiction to getting vaccinated with PREVNAR 13. The outcome of the events was unknown. The causality was also unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receivd from a registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were inadvertently administered with unknown number of doses of improperly stored VARIVAX (Merck) (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 8 months old patient of unknown gender. Concurrent conditions, medical history of the patient were not reported. On 23-MAR-2015 the patient was vaccinated with a dose of VAQTA (lot#, expiry date, dose, route unspecified) when the patient was 8 months old (Inappropriate scheudle of vacine administered). Concmitant therapies were not reported. No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure increased, Blood test, Malaise, Pain in extremity
Clinical narrative: Information has been received from a 74 years old male patient with high blood pressure, high cholesterol and drug allergies to penicillin and other unspecified medications. In late November 2014, the patient was vaccinated with ZOSTAVAX, 1 dose 0.65 ml, (lot#, expiration date, dose and route not reported). Concomitant therapies were not reported. The patient reported that he became ill a few days before Veterans Day in January 2015 (date unspecified). The illness that the patient experienced was an elevated blood pressure, severe headache and a rash on the right side near the hip area. The patient became ill again on 10-MAR-2015. The patient stated that this last illness included stomach troubles of him vomiting and being sick for several days. The wound on the patient's leg "bled a little bit" had soreness and painful to the touch (date unspecified). The patient had not recovered from the events Treatment of triamcinolone acetonide cream and other unspecified medications were given to the events. Blood work and other unspecified diagnostics were performed (results unknown). The patient went to ER but was not admitted tot he hospital. The causality was not provided. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting, Wound complication, Wound haemorrhage
Clinical narrative: Information has been received from a 74 years old male patient with high blood pressure, high cholesterol and drug allergies to penicillin and other unspecified medications. In late November 2014, the patient was vaccinated with ZOSTAVAX, 1 dose 0.65 ml, (lot#, expiration date, dose and route not reported). Concomitant therapies were not reported. The patient reported that he became ill a few days before Veterans Day in January 2015 (date unspecified). The illness that the patient experienced was an elevated blood pressure, severe headache and a rash on the right side near the hip area. The patient became ill again on 10-MAR-2015. The patient stated that this last illness included stomach troubles of him vomiting and being sick for several days. The wound on the patient's leg "bled a little bit" had soreness and painful to the touch (date unspecified). The patient had not recovered from the events Treatment of triamcinolone acetonide cream and other unspecified medications were given to the events. Blood work and other unspecified diagnostics were performed (results unknown). The patient went to ER but was not admitted tot he hospital. The causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions were reported for the patient. The reporter stated that the patient was vaccinated with first dose of GARDASIL on an unspecified date in 2013 and the 2nd dose of GARDASIL also on an unspecified date in 2013. The reporter stated that the patient was present in the unspecified physician's office on 24-MAR-2015, to receive the third dose of GARDASIL (Dose strength, route of all the doses vaccinated were unspecified) (inappropriate schedule of drug administration). No adverse effects reported. The outcome of events reported was unknown. No product quality complaint was involved. 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 nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-OCT-2014, the patient was vaccinated with the first dose of expired RECOMBIVAX HB lot # h010965, expiration date 01-JUN-2014, 10 micro-g/ml, route of administration not reported. On 20-JAN-2015, the patient was vaccinated with the second dose of expired RECOMBIVAX HB lot # h010965, expiration date 01-JUN-2014, 10 micro-g/ml, route of administration not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown ages and gender. On unknown dates the patients were vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose, strength and route were not reported) or PROQUAD (lot#, expiration date, dose, strength and route were not reported) which exposed to a maximum temperature of -6.2C for a total time of 5.5 hours. No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On 23-MAR-2015, the patient was vaccinated with the third dose of GARDASIL (0.5 ml dose, intramuscular injection, lot # 0420AE that was expired at the time of administration, the expiration date was reported as 01-DEC-2014. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information is not expected as no consent for contact was given.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a healthcare worker concerning an adult patient of unkonwn age and gender. No current or historical conditions were reported. On an unknown date between 18-FEB-2015 and 26-FEB-2015, the patient was inadvertently vaccinated with pediatric dose (unspecified in series) of RECOMBIVAX HB, 0.5 ml once, intramuscular (Accidental underdose). The administered dose could have been 1 of 2 lot numbers: lot# K008988 and expiration date 04-FEB-2016 or lot# K012469 and expiration 14-APR-2016. No adverse effects reported. Additional information has been requested.