chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Mother reported child woke up in the middle of the night with a fever (mother reports that they did not take a temp as they didn't have a thermometer at home).  Arms felt cramped.  No redness or swelling at sight of injection.  Denies any other s/s.  Child was at home when parent called.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Chills, Eye swelling, Headache, Hyperhidrosis
Clinical narrative: Headaches, chills, sweating, and some swelling. Member took multiple Tylenols to subside the pain. The same symptoms occurred again on 4/7/2014 but intensified. 4/8/2014 she was unable to attend work due to the above symptoms along with swollen eyes and tingling in the arms and legs.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Swelling
Clinical narrative: Headaches, chills, sweating, and some swelling. Member took multiple Tylenols to subside the pain. The same symptoms occurred again on 4/7/2014 but intensified. 4/8/2014 she was unable to attend work due to the above symptoms along with swollen eyes and tingling in the arms and legs.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Leg became red, swollen, hot to touch and tender at injection site.  Pt very irritable through out the night with fever no more than 100 degrees.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Leg became red, swollen, hot to touch and tender at injection site.  Pt very irritable through out the night with fever no more than 100 degrees.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Abasia, Dermatomyositis, Herpes zoster, Immunodeficiency, Musculoskeletal pain
Clinical narrative: HERPES ZOSTER DIAGNOSIS IN TWO DOSE VARICELLA VACCINE RECIPIENT. She is immunocompromised: dermatomyositis. Takes prednisone and mycophenolate. RASH LASTED LESS THAN FOUR WEEKS. LOCATION: ONE DERMATOME. TREATED WITH ACYCLOVIR. Went to ER on 3/18/2014 for severe leg pain- could not walk. Admitted at Hospital from 3/18- 3/22.  No sign of rash- they thought it was Amplified Musculoskeletal Pain Syndrome. 3/20 she developed rash- on 3/26 it worsened and that's when they consulted ID. Positive vaccine strain VZV lab results reported on 4/2/14.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pain in extremity, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: HERPES ZOSTER DIAGNOSIS IN TWO DOSE VARICELLA VACCINE RECIPIENT. She is immunocompromised: dermatomyositis. Takes prednisone and mycophenolate. RASH LASTED LESS THAN FOUR WEEKS. LOCATION: ONE DERMATOME. TREATED WITH ACYCLOVIR. Went to ER on 3/18/2014 for severe leg pain- could not walk. Admitted at Hospital from 3/18- 3/22.  No sign of rash- they thought it was Amplified Musculoskeletal Pain Syndrome. 3/20 she developed rash- on 3/26 it worsened and that's when they consulted ID. Positive vaccine strain VZV lab results reported on 4/2/14.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS, OF THE UPPER PART OF THE LEFT ARM.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Blister, Herpes zoster, Injection site vesicles, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: * NOTE: CHILD MAY HAVE BEEN LIVING IN A SHELTER. HERPES ZOSTER DIAGNOSIS IN ONE DOSE VARICELLA VACCINE RECIPIENT. BLISTERS. Left upper extremity, spread to hand.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Hard Dark Pink Left Arm.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Allergy test positive, Heart rate increased, Urticaria, Vomiting, Vomiting projectile
Clinical narrative: Patient began throwing up around 9:30 am. By 10:30 am she had thrown up twice and began showing signs of hives on her leg. By 11:30 the hives covered her body. She was taken to the emergency room where she was given a shot of epinephrine. When this happened her heart rate shot up, and she began to projectile vomit. After an hour the hives disappeared and then sent us home. Patient continued to throw-up at least once a day (at night) for one full week. After an allergy blood test it was determined that she now has a severe allergy to eggs which was not present at the time of the vaccination. She has been instructed to take Zyrtec, avoid egg foods, and carry an epi-pen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Patient woke up with slightly itchy face.  Face became red and slightly raised on cheeks, forehead, chin. No difficulty breathing, wheezing, or swelling of mouth, lips, eyes, or tongue.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Headache, Throat irritation
Clinical narrative: I woke up with a severe headache, upset stomach and throat irritation.  The symptoms lasted for 11 hours and worsened after eating.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site urticaria
Clinical narrative: Mom saw hives on hands and thighs and around the injection sites, transient, lasted only about 5 minutes and self resolved.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Localized pruritis, erythema, swelling.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: Took Tdap vaccine at around 10:30am on 04/08/2014. Symptoms: pain and swelling where the shot was given. Fever up to 101.5 F. Headache, tiredness, nausea, stomach ache, diarrhea. Chill, body aches and sore joints.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Took Tdap vaccine at around 10:30am on 04/08/2014. Symptoms: pain and swelling where the shot was given. Fever up to 101.5 F. Headache, tiredness, nausea, stomach ache, diarrhea. Chill, body aches and sore joints.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Took Tdap vaccine at around 10:30am on 04/08/2014. Symptoms: pain and swelling where the shot was given. Fever up to 101.5 F. Headache, tiredness, nausea, stomach ache, diarrhea. Chill, body aches and sore joints.
Age: 8.0
Sex: F
Vaccine: DTP
Symptoms: Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever and aches all over body.  No appetite.  Sore are site of shot.
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: Crying, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Baby began crying inconsolably and continued for about 5 hours.  Injection site was red, swollen, and warm to touch.  A few days later, I noticed a brown spotted permanent mark on baby's skin at the injection site, which still remains.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Local swelling, Pain, Pain in extremity
Clinical narrative: Body aches, fever, body rashes severe. Fever w/ rigors. Did not measure temp. Diarrhea at evening of 4/5/14. Sore arm - entire upper arm to elbow swollen and warm to touch.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised, Skin warm
Clinical narrative: Body aches, fever, body rashes severe. Fever w/ rigors. Did not measure temp. Diarrhea at evening of 4/5/14. Sore arm - entire upper arm to elbow swollen and warm to touch.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. The nurse did not provide if the patients were previously vaccinated with M-M-R II (dose, route, lot numbers and expiration dates were not provided either). On an unknown date, the nurse reported that her region was having an outbreak of mumps. At the time of the report, outcome for outbreak of mumps was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Eyelid function disorder
Clinical narrative: Unable to close right eye, seen at ED rx prednisone 50 mg, po, qd x 4 and antifacial tears.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administration error, No adverse event
Clinical narrative: Misadministration, no adverse event onset.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccination on 11-16-13. She came to pharmacy on 3-24-14 and stated that her arm was still hurting.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Discussed with patient that he was getting Tdap vaccine, gave VIS. Patient stated he had no allergies and was not on any meds. 15-20 minutes later, patient came back and stated that mother told him he had allergic reaction to pertussis as a child. Notified physician in building and took vital signs. Dr advised patient to go to ER and notify them of event. Patient stated that he felt "alright" and did not need to go to ER.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, swollen right arm. No pain or discomfort - just red, warm and swollen.
Age: 25.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Dizziness, Nausea, Presyncope, Vomiting
Clinical narrative: Client experienced dizziness, nausea and vomiting 5 minutes post vaccination; helped to couch and elevated the legs. Client took longer to recover than any episodes of vasovagal reaction. Encouraged to go to the doctor for consult - visited clinic; same day. Advised 70% likely to recur.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Child received vaccine on 4-1-14. Father of child called vaccine coordinator on 4-4-14 to report sore, red upper left arm. He also reported child had been keeping left arm immobile for 2 days at mother's direction. Vaccine coordinator instructed father to give child TYLENOL, apply ice and warm pack to arm and move arm. Father of child phoned by RN 3 hrs later and father reported child feeling better.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Itching, redness, knot at injection site for several days. Treated with BENADRYL, warm compress.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt states she was diagnosed with Guillain-Barre syndrome approx. 2 weeks after receiving vaccine.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients were vaccinated with PNEUMOVAX 23. On an unknown date the patient may had received improperly storaged PNEUMOVAX 23. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: This spontaneous report as received from a health care worker via inventive health field representative, refers to a 60 year old female patient. Medical history and concurrent conditions were not reported. On an unspecified date sometime in September 2013, the patient was vaccinated with ZOSTAVAX "one single shot", route "injection". Dose and lot number were not reported. In approximately 2013, 2 days after receiving ZOSTAVAX the patient developed a cellulitis like rash. The outcome of cellulitis like a rash was reported as recovering. No lab diagnostic studies were performed. The patient sought medical attention, saw the doctor. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender who on 07-APR-2014 the patient was vaccinated with MMR II lot # 0649AE, subcutaneous that had expired on 27-MAR-2014. No adverse event reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and the consumer's mother refers to a male patient of unknown age. The patients current conditions or medical history were not reported. On 21-MAY-2013 and 25-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB 5 mcg/0.5 ml (route, lot number and expiration date were not reported) that were stated by the physician's office to be invalid because they had a temperature stability issue. Those vaccines were apparently two degrees off 32 F for 30 minutes. On 02-AUG-2013, the patient was given a third dose of RECOMBIVAX HB 5 mcg/0.5 ml (route, lot number and expiration date were not reported) that was stated to be valid. No adverse experiences were reported. The reporter stated that the vaccines were given to the patient in a manner inconsistent with the prescribing information. It was also reported that the physician's office wanted to revaccinate the patient. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare professional regarding an unspecified number of patients of unknown age. On an unknown date, the unspecified patient received improperly stored oral ROTATEQ (dose was not provided, Lot number reported as J000987, expiration date 11-SEP-2014). Two doses of the improperly stored ROTATEQ were received on 28-MAR-2014. The improperly stored ROTATEQ was exposed to 13C for an undetermined timeframe. Healthcare worker will provide timeframe when products are back in recommended storage range. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a registered nurse refers to a dialysis patient of unknown age and gender. The patient's medical history was not reported. On 12-FEB-2014, the patient was vaccinated with the first dose of dialysis formulation of RECOMBIVAX HB 40 mg/ml (route, lot number and expiration date were not provided). On 21-MAR-2014, the patient received the second dose of ENGERIX B 20 mcg but the patient should had received 2 doses of ENGERIX-B. No adverse effect reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient. On 04-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H012972, expiration date: 09-MAR-2014), 0.5 ml, intramuscular in the right deltoid for an unknown indication. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients were vaccinated with Meningococcal Protein Conjugate (manufacturer unknown). On an unknown date the patient may had received improperly stored Meningococcal Protein Conjugate (manufacturer unknown). No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients were vaccinated with ROTATEQ. On an unknown date, the patient may had received improperly storaged ROTATEQ. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unspecified date, the patient was vaccinated with ZOSTAVAX one single shot, (lot number, dose and route not reported) for prevention of shingles. On an unknown date, five days after receiving ZOSTAVAX, the patient developed a rash. At the time of the report, the patient's outcome for rash was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients were vaccinated with GARDASIL. On an unknown date the patient may had received improperly storaged GARDASIL. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Muscle twitching, Paraesthesia
Clinical narrative: Based on additional information received on 03 April 2014, this case initially considered as non-serious was upgraded to serious: numbness and tingling in vaccinated arm for three months. Initial report received from a health care professional on 06 January 2014. A female patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE INTRADERMAL (Dose number, route and site of vaccination was not reported, Lot number UT4725AA, expiry date: 19 April 2014) on an unspecified date on 18 December 2013. It was reported that after vaccination the patient had experienced tingling and twitching of her arm. The patient has had same symptoms and was last checked on 23 December 2013. Laboratory details and corrective treatment were not reported. The outcome of the adverse event was unknown. Documents held by sender: none. Follow up information received from healthcare professional on 10 February 2014. A 36-year-old female patient received second dose of FLUZONE intradermal vaccine intradermally in the left arm on 17 December 2013 (previously reported as 18 December 2013) at 4:55 pm. Preexisting physician diagnosed allergies, birth defects, medical condition and relevant laboratory details were reported as "NA". The event started immediately after vaccination on an unspecified date. As of 30 December 2013 the patient was not recovered. Additional information was received from the health care professional on 03 April 2014. The patient's symptoms started on 17 December 2013, and became progressively worse, described as tingling and numbness radiating all the way down to the fingers of her left arm, over a period of three months. She stated that she had "no use of her left arm". She was seen by her private physician, who informed her that the symptoms "would go away on it's own". On 07 March 2014 the symptoms suddenly resolved without any treatment. The patient was considered to be fully recovered.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Muscle twitching, Paraesthesia
Clinical narrative: Based on additional information received on 03 April 2014, this case initially considered as non-serious was upgraded to serious: numbness and tingling in vaccinated arm for three months. Initial report received from a health care professional on 06 January 2014. A female patient, whose medical history and concomitant medications were not reported, received a dose of FLUZONE INTRADERMAL (Dose number, route and site of vaccination was not reported, Lot number UT4725AA, expiry date: 19 April 2014) on an unspecified date on 18 December 2013. It was reported that after vaccination the patient had experienced tingling and twitching of her arm. The patient has had same symptoms and was last checked on 23 December 2013. Laboratory details and corrective treatment were not reported. The outcome of the adverse event was unknown. Documents held by sender: none. Follow up information received from healthcare professional on 10 February 2014. A 36-year-old female patient received second dose of FLUZONE intradermal vaccine intradermally in the left arm on 17 December 2013 (previously reported as 18 December 2013) at 4:55 pm. Preexisting physician diagnosed allergies, birth defects, medical condition and relevant laboratory details were reported as "NA". The event started immediately after vaccination on an unspecified date. As of 30 December 2013 the patient was not recovered. Additional information was received from the health care professional on 03 April 2014. The patient's symptoms started on 17 December 2013, and became progressively worse, described as tingling and numbness radiating all the way down to the fingers of her left arm, over a period of three months. She stated that she had "no use of her left arm". She was seen by her private physician, who informed her that the symptoms "would go away on it's own". On 07 March 2014 the symptoms suddenly resolved without any treatment. The patient was considered to be fully recovered.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Altered state of consciousness, Flushing, Somnolence
Clinical narrative: Case number PHHY2014US042878 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521809) web site on 08 Apr 2014. This report refers to a 42 year old male patient. His medical history and concomitant medications were not reported. It was reported that several years ago he passed out after receiving a seasonal influenza vaccine (see case number: PHHY2014US043008) but after that seasonal influenza vaccine in every year were well tolerated. On 04 Feb 2014, he was vaccinated with FLUVIRIN (batch number: 1309101) intramuscularly into right arm. On the same day within about 10 seconds after vaccination, he felt very sleepy. Reporter talked to him through the entire incident which lasted approximately for 5 minutes. He felt flushing all over his body, but did not feel lightheaded, nauseous or lose consciousness. The flushing was the only symptom reported, although he appeared to be close to losing consciousness. The outcome of the events was reported as complete recovery. The event was reported as non serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported.
Age: 42.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Altered state of consciousness, Flushing, Immediate post-injection reaction, Somnolence
Clinical narrative: Case number PHHY2014US042878 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521809) web site on 08 Apr 2014. This report refers to a 42 year old male patient. His medical history and concomitant medications were not reported. It was reported that several years ago he passed out after receiving a seasonal influenza vaccine (see case number: PHHY2014US043008) but after that seasonal influenza vaccine in every year were well tolerated. On 04 Feb 2014, he was vaccinated with FLUVIRIN (batch number: 1309101) intramuscularly into right arm. On the same day within about 10 seconds after vaccination, he felt very sleepy. Reporter talked to him through the entire incident which lasted approximately for 5 minutes. He felt flushing all over his body, but did not feel lightheaded, nauseous or lose consciousness. The flushing was the only symptom reported, although he appeared to be close to losing consciousness. The outcome of the events was reported as complete recovery. The event was reported as non serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Got pneumo shot at clinic. By evening c/o arm pain and unable to sleep due to pain. Developed a fever of 100.2 and red raised rash on deltoid area. Area continued to hurt and rash extended during the day of 4/9/14. Instructed to use topical and oral BENADRYL.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Pain in extremity, Pyrexia, Rash, Rash erythematous
Clinical narrative: Got pneumo shot at clinic. By evening c/o arm pain and unable to sleep due to pain. Developed a fever of 100.2 and red raised rash on deltoid area. Area continued to hurt and rash extended during the day of 4/9/14. Instructed to use topical and oral BENADRYL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Asthenia, Chest pain, Pallor
Clinical narrative: Approximately five to ten minutes after receiving the DTap vaccine, patient started to complain that his chest hurt. This progressively got worse, he turned very pale and weak. We left the doctors office and within five minutes went back. Patient never lost consciousness but continued to complain of chest pains, asking to go back to the doctor's office and was very weak. I carried him into the doctor's office, the doctor checked patient's pulse and heart rate and said they were normal. After lying down at the doctor's office, patient had color back in his face, said his chest no longer hurt and seemed to be himself. This was very frightening for me. He has never had a reaction to a vaccination prior to this.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a 15 unspecified patients of unknown gender and unknown age. The reporting physician informed the representative that a friend of his posted an unspecified link on Facebook stating that 15 unspecified patients died after receiving GARDASIL (dose, lot/batch number, expiry date and indication was not reported). The physician would like to know where the information was coming from. The representative did not have any further information by the time of the report. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Abdominal pain upper, Adverse drug reaction, Anxiety, Biopsy
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no known drug reactions/allergies. On 03-MAR-2009 the patient was vaccinated with the first dose of GARDASIL (lot # 661703/0651X, exp date 19-FEB-2011). On 13-MAY-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). On 09-SEP-2009 the patient was vaccinated with the third dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). There was no concomitant therapy. The reporter stated that in "September of 2009" the patient became sick after receiving the 3rd and final dose of GARDASIL (09-SEP-2009). Sometime "after school started" in September 2009, patient began vomiting, having headaches and feeling dizzy. She was seen by an unspecified family doctor, and then by several specialists. She was taken to the ER (emergency room) several times; her first visit was "4 and a half" years ago. Patient was experiencing abnormal heart rate, chest pain, rashes and ringing in ears. One year after the 3rd GARDASIL shot, she had weekly visits, for numerous tests, at Hospital. No diagnosis was made, and patient was prescribed unspecified drugs for anxiety and depression; Reporter said the drugs made patient "more tired". She also had hospital visits (dates, location unspecified) for "scopes", with "two down her throat and one in her rectum" which were inconclusive. Four years ago patient had her gallbladder removed at hospital, where she stayed for 2 days. Upon biopsy of gallbladder, unspecified HCP who performed the surgery, stated there were "slight abrasions" on the gallbladder but "nothing that would cause severe stomach pain." At an unspecified date, patient's "bilirubin was off" and had to take OXYCONTIN. Patient still had stomach pains daily, as well as extreme fatigue. Patient took fluoxetine for anxiety and depression, which reporter said, made her more tired; ADDERALL, which upset her stomach; DEXILANT for the stomach pain and IMITREX for migraines. Lab diagnostics studies performed included scopes, MRI (Magnetic Resonance Imaging), CT scan, EKG (electrocardiogram) and biopsy. At the time of this report, the patient had not recovered from stomach pains as well as extreme fatigue. The outcome of other events were unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood bilirubin decreased, Chest pain, Cholecystectomy, Computerised tomogram, Depression
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no known drug reactions/allergies. On 03-MAR-2009 the patient was vaccinated with the first dose of GARDASIL (lot # 661703/0651X, exp date 19-FEB-2011). On 13-MAY-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). On 09-SEP-2009 the patient was vaccinated with the third dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). There was no concomitant therapy. The reporter stated that in "September of 2009" the patient became sick after receiving the 3rd and final dose of GARDASIL (09-SEP-2009). Sometime "after school started" in September 2009, patient began vomiting, having headaches and feeling dizzy. She was seen by an unspecified family doctor, and then by several specialists. She was taken to the ER (emergency room) several times; her first visit was "4 and a half" years ago. Patient was experiencing abnormal heart rate, chest pain, rashes and ringing in ears. One year after the 3rd GARDASIL shot, she had weekly visits, for numerous tests, at Hospital. No diagnosis was made, and patient was prescribed unspecified drugs for anxiety and depression; Reporter said the drugs made patient "more tired". She also had hospital visits (dates, location unspecified) for "scopes", with "two down her throat and one in her rectum" which were inconclusive. Four years ago patient had her gallbladder removed at hospital, where she stayed for 2 days. Upon biopsy of gallbladder, unspecified HCP who performed the surgery, stated there were "slight abrasions" on the gallbladder but "nothing that would cause severe stomach pain." At an unspecified date, patient's "bilirubin was off" and had to take OXYCONTIN. Patient still had stomach pains daily, as well as extreme fatigue. Patient took fluoxetine for anxiety and depression, which reporter said, made her more tired; ADDERALL, which upset her stomach; DEXILANT for the stomach pain and IMITREX for migraines. Lab diagnostics studies performed included scopes, MRI (Magnetic Resonance Imaging), CT scan, EKG (electrocardiogram) and biopsy. At the time of this report, the patient had not recovered from stomach pains as well as extreme fatigue. The outcome of other events were unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram, Endoscopy, Fatigue, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no known drug reactions/allergies. On 03-MAR-2009 the patient was vaccinated with the first dose of GARDASIL (lot # 661703/0651X, exp date 19-FEB-2011). On 13-MAY-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). On 09-SEP-2009 the patient was vaccinated with the third dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). There was no concomitant therapy. The reporter stated that in "September of 2009" the patient became sick after receiving the 3rd and final dose of GARDASIL (09-SEP-2009). Sometime "after school started" in September 2009, patient began vomiting, having headaches and feeling dizzy. She was seen by an unspecified family doctor, and then by several specialists. She was taken to the ER (emergency room) several times; her first visit was "4 and a half" years ago. Patient was experiencing abnormal heart rate, chest pain, rashes and ringing in ears. One year after the 3rd GARDASIL shot, she had weekly visits, for numerous tests, at Hospital. No diagnosis was made, and patient was prescribed unspecified drugs for anxiety and depression; Reporter said the drugs made patient "more tired". She also had hospital visits (dates, location unspecified) for "scopes", with "two down her throat and one in her rectum" which were inconclusive. Four years ago patient had her gallbladder removed at hospital, where she stayed for 2 days. Upon biopsy of gallbladder, unspecified HCP who performed the surgery, stated there were "slight abrasions" on the gallbladder but "nothing that would cause severe stomach pain." At an unspecified date, patient's "bilirubin was off" and had to take OXYCONTIN. Patient still had stomach pains daily, as well as extreme fatigue. Patient took fluoxetine for anxiety and depression, which reporter said, made her more tired; ADDERALL, which upset her stomach; DEXILANT for the stomach pain and IMITREX for migraines. Lab diagnostics studies performed included scopes, MRI (Magnetic Resonance Imaging), CT scan, EKG (electrocardiogram) and biopsy. At the time of this report, the patient had not recovered from stomach pains as well as extreme fatigue. The outcome of other events were unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate abnormal, Laboratory test, Malaise, Migraine, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no known drug reactions/allergies. On 03-MAR-2009 the patient was vaccinated with the first dose of GARDASIL (lot # 661703/0651X, exp date 19-FEB-2011). On 13-MAY-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). On 09-SEP-2009 the patient was vaccinated with the third dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). There was no concomitant therapy. The reporter stated that in "September of 2009" the patient became sick after receiving the 3rd and final dose of GARDASIL (09-SEP-2009). Sometime "after school started" in September 2009, patient began vomiting, having headaches and feeling dizzy. She was seen by an unspecified family doctor, and then by several specialists. She was taken to the ER (emergency room) several times; her first visit was "4 and a half" years ago. Patient was experiencing abnormal heart rate, chest pain, rashes and ringing in ears. One year after the 3rd GARDASIL shot, she had weekly visits, for numerous tests, at Hospital. No diagnosis was made, and patient was prescribed unspecified drugs for anxiety and depression; Reporter said the drugs made patient "more tired". She also had hospital visits (dates, location unspecified) for "scopes", with "two down her throat and one in her rectum" which were inconclusive. Four years ago patient had her gallbladder removed at hospital, where she stayed for 2 days. Upon biopsy of gallbladder, unspecified HCP who performed the surgery, stated there were "slight abrasions" on the gallbladder but "nothing that would cause severe stomach pain." At an unspecified date, patient's "bilirubin was off" and had to take OXYCONTIN. Patient still had stomach pains daily, as well as extreme fatigue. Patient took fluoxetine for anxiety and depression, which reporter said, made her more tired; ADDERALL, which upset her stomach; DEXILANT for the stomach pain and IMITREX for migraines. Lab diagnostics studies performed included scopes, MRI (Magnetic Resonance Imaging), CT scan, EKG (electrocardiogram) and biopsy. At the time of this report, the patient had not recovered from stomach pains as well as extreme fatigue. The outcome of other events were unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Tinnitus, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to her 13 year old daughter with no pertinent medical history and no known drug reactions/allergies. On 03-MAR-2009 the patient was vaccinated with the first dose of GARDASIL (lot # 661703/0651X, exp date 19-FEB-2011). On 13-MAY-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). On 09-SEP-2009 the patient was vaccinated with the third dose of GARDASIL (lot # 660387/1967U, exp date 06-OCT-2010). There was no concomitant therapy. The reporter stated that in "September of 2009" the patient became sick after receiving the 3rd and final dose of GARDASIL (09-SEP-2009). Sometime "after school started" in September 2009, patient began vomiting, having headaches and feeling dizzy. She was seen by an unspecified family doctor, and then by several specialists. She was taken to the ER (emergency room) several times; her first visit was "4 and a half" years ago. Patient was experiencing abnormal heart rate, chest pain, rashes and ringing in ears. One year after the 3rd GARDASIL shot, she had weekly visits, for numerous tests, at Hospital. No diagnosis was made, and patient was prescribed unspecified drugs for anxiety and depression; Reporter said the drugs made patient "more tired". She also had hospital visits (dates, location unspecified) for "scopes", with "two down her throat and one in her rectum" which were inconclusive. Four years ago patient had her gallbladder removed at hospital, where she stayed for 2 days. Upon biopsy of gallbladder, unspecified HCP who performed the surgery, stated there were "slight abrasions" on the gallbladder but "nothing that would cause severe stomach pain." At an unspecified date, patient's "bilirubin was off" and had to take OXYCONTIN. Patient still had stomach pains daily, as well as extreme fatigue. Patient took fluoxetine for anxiety and depression, which reporter said, made her more tired; ADDERALL, which upset her stomach; DEXILANT for the stomach pain and IMITREX for migraines. Lab diagnostics studies performed included scopes, MRI (Magnetic Resonance Imaging), CT scan, EKG (electrocardiogram) and biopsy. At the time of this report, the patient had not recovered from stomach pains as well as extreme fatigue. The outcome of other events were unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Impaired driving ability, Injection site erythema, Injection site urticaria, Mobility decreased
Clinical narrative: C/o severe pain and reddness since the evening of injection.  Took Tylenol PM for the pain last evening.  Member stated limited ROM due to pain, difficult to drive and dress this am. Several red patches noted on R deltoid, member denied itching, but stated severe pain. Was seen by Dr. stated the red patches were hives.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: C/o severe pain and reddness since the evening of injection.  Took Tylenol PM for the pain last evening.  Member stated limited ROM due to pain, difficult to drive and dress this am. Several red patches noted on R deltoid, member denied itching, but stated severe pain. Was seen by Dr. stated the red patches were hives.
Age: 0.34
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Mass, Rash, Screaming
Clinical narrative: Screaming, fussiness, lump on leg and rash.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Feeling cold, Feeling hot, Flushing, Headache
Clinical narrative: Malaise on 4/8/14 9:00 pm. Question of fever 4/8/14 at 900 pm felt warm then cold. Sweaty this morning 4/9/14 at 900 AM. States her head feels full and myalgias all over neck. Question of a reaction to MENACTRA vaccine given abt 24 hours ago. C/O H/A and fatigue symptom started last night. Felt totally fine until tried to fall asleep last night, had considerably more trouble than usual. Malaise didn't feel well. Achy arm started last night, until evening time felt totally herself. Went to school and lacrosse. Has been practicing lacrosse a couple weeks. ?Fever last night. Warm then cold. Sweaty this AM when woke up. Face flushed. No HA per se but head feels full. No nasal congestion. No cough. No diarrhea. No nausea or abdom pain. Some myalgias all over and neck. Denies rash and itchy skin. No sore throat. Mom thinks may have had some reaction to MENACTRA first dose, but not signif enough that was seen or recorded in chart in my review of such and patient herself doesn't remember it.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Initial insomnia, Malaise, Myalgia, Pain in extremity
Clinical narrative: Malaise on 4/8/14 9:00 pm. Question of fever 4/8/14 at 900 pm felt warm then cold. Sweaty this morning 4/9/14 at 900 AM. States her head feels full and myalgias all over neck. Question of a reaction to MENACTRA vaccine given abt 24 hours ago. C/O H/A and fatigue symptom started last night. Felt totally fine until tried to fall asleep last night, had considerably more trouble than usual. Malaise didn't feel well. Achy arm started last night, until evening time felt totally herself. Went to school and lacrosse. Has been practicing lacrosse a couple weeks. ?Fever last night. Warm then cold. Sweaty this AM when woke up. Face flushed. No HA per se but head feels full. No nasal congestion. No cough. No diarrhea. No nausea or abdom pain. Some myalgias all over and neck. Denies rash and itchy skin. No sore throat. Mom thinks may have had some reaction to MENACTRA first dose, but not signif enough that was seen or recorded in chart in my review of such and patient herself doesn't remember it.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: Malaise on 4/8/14 9:00 pm. Question of fever 4/8/14 at 900 pm felt warm then cold. Sweaty this morning 4/9/14 at 900 AM. States her head feels full and myalgias all over neck. Question of a reaction to MENACTRA vaccine given abt 24 hours ago. C/O H/A and fatigue symptom started last night. Felt totally fine until tried to fall asleep last night, had considerably more trouble than usual. Malaise didn't feel well. Achy arm started last night, until evening time felt totally herself. Went to school and lacrosse. Has been practicing lacrosse a couple weeks. ?Fever last night. Warm then cold. Sweaty this AM when woke up. Face flushed. No HA per se but head feels full. No nasal congestion. No cough. No diarrhea. No nausea or abdom pain. Some myalgias all over and neck. Denies rash and itchy skin. No sore throat. Mom thinks may have had some reaction to MENACTRA first dose, but not signif enough that was seen or recorded in chart in my review of such and patient herself doesn't remember it.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 14-AUG-2012, the patient was vaccinated with the first 0.5ml dose of GARDASIL intramuscularly. On 25-MAR-2014 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular late. No adverse effects reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The nurse stated that on 30-DEC-2013, the patient (reported as client) was vaccinated with ZOSTAVAX Lot # J00F4211, Expiry date-September 2014, dose 0.65 ml, subcutaneous in the right arm (indication was reported as vaccine). The nurse reported that pharmacy got a call stating that patient had an adverse reaction. On an unknown date the patient developed pain in her right arm and the patient went to see her specialist, a rheumatologist. The rheumatologist diagnosed the patient with Polymyalgia rheumatica. The outcome of polymyalgia rheumatica was reported as not recovered/not resolved. Action taken with suspect product was not applicable. The patient sought medical attention. No product quality complaint was involved. The causality assessment was not provided. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Rash erythematous
Clinical narrative: Wrist pain/stiffness bilaterally x 1 day.  Febrile.  Minimal flat red rash to arms, trunk and face ongoing x 2 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-APR-2014 the patient was vaccinated with VARIVAX (Merck) that was improperly stored, 0.5 ml, subcutaneous (lot# not provided). No adverse effects reported. Product quality complaint was not involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, tender and hot area on right thigh where she received vaccinations 3/31/2014.  Fever for 2 days up to 102 F.  Limping some on that leg.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Red, raised, tender and hot area on right thigh where she received vaccinations 3/31/2014.  Fever for 2 days up to 102 F.  Limping some on that leg.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (reported as medical assistant and healthcare worker) refers to unspecified number of patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. It was reported that from an unknown date the ZOSTAVAX was improperly stored for a full year and on an unknown date unspecified number of patients were vaccinated with ZOSTAVAX (dose strength, indication route was not reported). It was unspecified as how many doses were administered to how many patients with this improperly stored ZOSTAVAX. The reporter considered no adverse effect and improperly stored to be not related to ZOSTAVAX. No product quality compliant was involved. This case is linked to the case 1404USA005084. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Scar, Thermal burn
Clinical narrative: This spontaneous report was received from a female of unknown age regarding herself. The patient had history of allergy to penicillin, allergy to sulfa and high blood pressure. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration was not provided). Concomitant therapies included LIPITOR and CENTRUM, unspecified medications for high blood pressure and Allopurinol (also reported as Alpurinol) to prevent kidney stones. On an unknown date in February 2012, the patient developed shingles on her neck and then on her scalp and they burned but did not itch. The patient received pills as treatment Valacyclovir and she recently finished. The patient stated that her mother has shingles and she did not want to get them, as they were awful. The patient also stated that she was completely over it now and there was just a little red scar on her neck. No laboratory diagnostic tests were performed. The outcome of the events were reported as resolving. The patient sought medical attention. Additional information has been requested.