chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates, multiple unspecified patients were vaccinated with doses of VAQTA (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates,  multiple unspecified patients were vaccinated with doses of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the 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 ws received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates, multiple unspecified patients were vaccinated with dose of ROTATEQ (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports form the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. on unknown dates, multiple unspecified patients were vaccinated with doses of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers an 8 year old female patient. On an unspecified date the patient developed chicken pox after receiving VARIVAX (Merck) (lot# unspecified) (dose, route and location unspecified). At the time of report, the outcome of event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypersensitivity, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 13 years old female patient with a drug reaction (rash) to ZITHROMAX. On 25-JUL-2013 the patient was vaccinated with a dose of GARDASIL (lot#, dose and route not provided). Concomitant medications were not reported. On 25-JUL-2013, the patient developed dizziness "within minutes" of receiving the dose of GARDASIL. The patient was asked to lie down in the physician's office, and while she was lying down, she developed a rash on her chest. The physician did not provide any further description of the patient's rash except to clarify that the patient appeared to be having an allergic reaction to the GARDASIL dose. The patient received an unspecified dose of BENADRYL, and after an unspecified period of time, the patient recovered and was released from the physician's practice to go home. The patient did not experience any further adverse effects. The patient had a family history of an allergy to Penicillin which manifested as a rash. No lab diagnostics studies were performed. The outcome of the event was recovered on 25-JUL-2013. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning multiple unspecified patients of unknown age and gender. On unknown dates, multiple unspecified patients were vaccinated with doses of M-M-R II (lot number, expiry date, dose and route unspecified) that may have gone through an unsupported temperature excursion. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a 27 year old patient. Pertinent medical history, allergies or drug reactions were not reported. On 15-SEP-2013 the patient was vaccinated with the first dose of GARDASIL, the second dose of GARDASIL was applied on 15-JAN-2009 and the third dose of GARDASIL was applied on 15-SEP-2013. Concentration, route of administration, dose and duration were not reported for all doses. Concomitant medications were not reported. No adverse events were mentioned. Additional information has been requested.
Age: 1.29
Sex: M
Vaccine: HEPA, DTAP, HEPA
Symptoms: Unevaluable event
Clinical narrative: Child had fever. Was taken to ER, seizure. Treated at ER. Followed up in office. Labs normal.
Age: 1.29
Sex: M
Vaccine: HEPA, DTAP, HEPA
Symptoms: Convulsion, Laboratory test normal, Pyrexia
Clinical narrative: Child had fever. Was taken to ER, seizure. Treated at ER. Followed up in office. Labs normal.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5, 6VAX-F, PPV, RV5
Symptoms: Death
Clinical narrative: DEATH.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea haemorrhagic, Shigella test positive
Clinical narrative: Patient received RotaTeq 09/24/2013 and started having bloody diarrhea two days later. We sent stool samples off and were positive for shigella.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Cold sweat, Dizziness, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: I felt chills and very achy (limbs and muscles ached) for about 24 hours.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Headache, Hypokinesia, Pain in extremity
Clinical narrative: I felt chills and very achy (limbs and muscles ached) for about 24 hours.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: I felt chills and very achy (limbs and muscles ached) for about 24 hours.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site urticaria, Skin warm, Swelling, Urticaria
Clinical narrative: Hives on arm (not just around injection site), swelling and redness of warm and fingers. Hives on torso.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on forearms, thigh, lower back for several days duration.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Radiculitis brachial
Clinical narrative: I woke up with terrible pain in left arm...radiating down into left hand..weakness developed to point where unable to move arm at shoulder. (My arm was sore from the evening of the injection, but flu shots generally do that...this became severe on 9/24/13).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea, Pain in extremity
Clinical narrative: Pt. c/o sudden onset of severe aching in arm. Pt. reports arm became cold to touch for 6 hrs. with c/o stomach ache, nausea, diarrhea et HA of sudden onset.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness
Clinical narrative: Pt. c/o sudden onset of severe aching in arm. Pt. reports arm became cold to touch for 6 hrs. with c/o stomach ache, nausea, diarrhea et HA of sudden onset.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Scab
Clinical narrative: Rash that appeared similarly to a scab.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # not reported) dose, frequency and route not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patient's experienced mild, zoster type rashes. The outcome of experienced mild, zoster type rashes was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. On 05-AUG-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly and subsequently was vaccinated with the second dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly on 01-OCT-2013. No concomitant therapy was reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 1.14
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Electroencephalogram normal, Febrile convulsion, Pyrexia
Clinical narrative: This medically confirmed report (initial receipt 24-Sep-2013) concerns a 2 years old male patient who had a medical history of egg allergy and developed rash due to egg allergy. On an unspecified date in Aug 2012, the patient received FLUVAX (batch number not provided). On an unspecified date, 3 weeks after his first vaccination with FLUVAX, the patient developed a febrile seizure. He was evaluated at the hospital emergency room. His fever was treated and he was not admitted. The next week, the patient experienced two seizures in a single day. Two weeks later, the patient experienced another seizure and was admitted to hospital. An electroencephalogram was performed which was normal. The patient recovered and was discharged from the hospital. On 20-Sep-2013, the patient experienced a febrile seizure. A pediatrician told the reporter that the seizures were unrelated to FLUVAX. Outcome was not yet recovered.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 65 year old male patient with coronary bypass. On an unknown date the patient was vaccinated with PNEUMOVAX23, injection (lot# and dose not reported). It was reported by the pharmacist who administered the vaccine that the patient at an unspecified time, complained of body aches and headache "shortly" after administration. No treatment was received. The pharmacist reported that the adverse symptoms resolved within 48 hours from time of administration. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Decreased appetite, Feeling abnormal, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: This spontaneous report as received from a nurse via a representative refers to a male patient of unknown age. On 01-MAY-2013 the patient was vaccinated with the first dose of ROTATEQ by oral. On 18-JUL-2013 the patient was vaccinated with the second dose of ROTATEQ by oral. ON 28-AUG-2013 the patient was vaccinated with the third dose of ROTATEQ by oral. On 09-SEP-2013, the patient's mother took him to the nurse's office, said that he had no appetite and was "not being himself". On 12-SEP-2013, an ultrasound was performed and the patient was sent to the emergency room (ER) due to "intussusception". Patient received unspecified treatment. No surgery had to be performed. On unknown date in 2013, the patient had recovered from the events. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a male patient of unknown age. On an unknown date in SEP-2013 (reported as last Wednesday), the patient was vaccinated with ZOSTAVAX, (lot number, expiry date was unknown). On an unknown date, the patient experienced side effects. The outcome of side effects was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. It was reported that the interruption in the vaccination schedule for GARDASIL (lot number, expiry date, dose and route unspecified) between the first and second doses also happened (dates of vaccination were unspecified). No concomitant therapy was reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction. Swelling, redness and rash spread around injection site about 2-3 inch x 1-2 in ribbon. Minor itching. MD treated with hydrocortisone 1% cream.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age. On 09-SEP-2013 the patient was vaccinated with the dose of ZOSTAVAX (dose, route of administration and lot number were not reported). On 23-SEP-2013, the patient was vaccinated with the dose of Yellow Fever virus vaccine. The nurse states that the patient received two live vaccines within a little over a two week time period. No adverse effect reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report was received from a 77 year old female patient regarding herself. Patient's current condition included asthma. No drug reactions were reported. On 16-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# expiry not reported). On an unknown date in approximately September 2013, the patient was vaccinated with a dose of Influenza virus vaccine (manufacturer unknown). Concomitant therapies included fluticasone propionate, Advair and Singulair. On 17-SEP-2013, the patient experienced flu like symptoms. Patient received treatment with unspecified over the counter decongestant. No laboratory tests were performed. No medical attention was sought. The outcome of flu like symptoms was reported as not recovered. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Asthenia, Cough, Decreased appetite, Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report was received from a 77 year old female patient regarding herself. Patient's current condition included asthma. No drug reactions were reported. On 16-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# expiry not reported). On an unknown date in approximately September 2013, the patient was vaccinated with a dose of Influenza virus vaccine (manufacturer unknown). Concomitant therapies included fluticasone propionate, Advair and Singulair. On 17-SEP-2013, the patient experienced flu like symptoms. Patient received treatment with unspecified over the counter decongestant. No laboratory tests were performed. No medical attention was sought. The outcome of flu like symptoms was reported as not recovered. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Rhinitis
Clinical narrative: This spontaneous report was received from a 77 year old female patient regarding herself. Patient's current condition included asthma. No drug reactions were reported. On 16-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# expiry not reported). On an unknown date in approximately September 2013, the patient was vaccinated with a dose of Influenza virus vaccine (manufacturer unknown). Concomitant therapies included fluticasone propionate, Advair and Singulair. On 17-SEP-2013, the patient experienced flu like symptoms. Patient received treatment with unspecified over the counter decongestant. No laboratory tests were performed. No medical attention was sought. The outcome of flu like symptoms was reported as not recovered. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Swelling face, Tongue disorder, Vaccination complication
Clinical narrative: Flu shot 9/30/13. Thurs. AM facial swelling, in PM tongue "funny". BENADRYL given and went to MD. MD ? related to flu shot vs. allergic reaction to something else.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed Practical Nurse regarding a male patient of unknown age. The patient's medical history, drug reactions or allergies were not provided. Two years ago, approximately in 2011, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not provided). On 19-SEP-2013, the patient was in office to receive a 3rd dose of GARDASIL approximately two years after the second dose was administered. Dose has not been administered yet. The patient did not received treatment for the adverse event and did not sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown dates the patient was vaccinated with a first and second doses of GARDASIL (lot numbers, doses, sites and routes of administration were not reported). On an unknown dates the patient experienced syncopal episodes after both 1st and 2nd dose of GARDASIL. The outcome of syncopal episodes was not reported. The relatedness between vaccination with GARDASIL and syncopal episodes was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-OCT-2013the patient was administered expired MMR II (lot# 1373AA, expiry date: 26-AUG-2013 as reported) route, dose and location unspecified. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Local swelling, Pruritus
Clinical narrative: Extremely swollen arm, itching, burning; headache.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea occurred persisted 5 days.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Aches, fever, shakes, nausea, headache Tylenol extra strength.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash generalised, Swelling
Clinical narrative: Right side of neck-back painful bump, two days later second painful bump appeared bethind left ear plus low-grade fever, Saturday 10/05 upper chest and back rash appeared, fever continued.  Went to clinic Saturday, started on medication - Allegra. Sunday rash was all over face and body.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysphagia, Flushing, Tongue disorder
Clinical narrative: About 6-12 hours after patient got high-dose flu vaccine from retail pharmacy, she experienced facial flushing, chest tightness, trouble swallowing and felt like her tongue was thicker. Her temperature at the time was 96.8F. She called her PCP office, who advised her to go to the ED. At the ED her symptoms subsided before any treatment and she took a Zyrtec before returning home. The total duration of her symptoms were 1-2 hours. This was her first time receiving the high dose vaccine, but has gotten the regular flu shot in the past without issues.
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm became red, swollen, and very hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMR, VARZOS
Symptoms: Erythema, Induration, Local swelling, Pruritus, Skin warm
Clinical narrative: Swollen left arm, redness, itching and hard hot area size of egg.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching arms and neck.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Lethargy, Oropharyngeal pain, Productive cough
Clinical narrative: Productive cough, green sputum, vomiting, sore throat, headache, fever, chills, sinus congestion, and lethargy. No treatment recommended by Physician.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Sinus congestion, Sputum purulent, Vomiting
Clinical narrative: Productive cough, green sputum, vomiting, sore throat, headache, fever, chills, sinus congestion, and lethargy. No treatment recommended by Physician.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Feeling of numbness in arm and throat.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Gastrointestinal disorder, Nasopharyngitis, Pain in extremity
Clinical narrative: Sore arm on 9/22/13. On 9/29/13 developed GI symptoms diarrhea, cough, cold, fever.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Sore arm on 9/22/13. On 9/29/13 developed GI symptoms diarrhea, cough, cold, fever.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was administered expired MMR II (lot# 1373AA, expiry date: 26-AUG-2013 as reported) route, dose and location unspecified. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same reported. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Rash pustular
Clinical narrative: DEVELOPED CLEAR PUSTULE-LIKE LESIONS ON LEGS (SHOT WAS GIVEN IN THE DELTOID).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash at injection site.  Fever 102.5.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Asthenia, Fatigue, Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Lower body ache, low fever, physical weakness and tiredness, large warm red patch at injection site.  On 10/05/2013 had fever of 103.2, body aches, red patch on arm about 5X4", red and hot.  Went to Immediate Care, Dxd cellulitis at injection site and UTE, started Keflex. On 10/08/2013 (time of reporting) symptoms are improved, inflammation site smaller; less red, less hot.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Lower body ache, low fever, physical weakness and tiredness, large warm red patch at injection site.  On 10/05/2013 had fever of 103.2, body aches, red patch on arm about 5X4", red and hot.  Went to Immediate Care, Dxd cellulitis at injection site and UTE, started Keflex. On 10/08/2013 (time of reporting) symptoms are improved, inflammation site smaller; less red, less hot.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Back pain, Body temperature increased, Cellulitis, Injection site pain, Local swelling
Clinical narrative: Lower body ache, low fever, physical weakness and tiredness, large warm red patch at injection site.  On 10/05/2013 had fever of 103.2, body aches, red patch on arm about 5X4", red and hot.  Went to Immediate Care, Dxd cellulitis at injection site and UTE, started Keflex. On 10/08/2013 (time of reporting) symptoms are improved, inflammation site smaller; less red, less hot.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pollakiuria, Skin warm, Swelling
Clinical narrative: Lower body ache, low fever, physical weakness and tiredness, large warm red patch at injection site.  On 10/05/2013 had fever of 103.2, body aches, red patch on arm about 5X4", red and hot.  Went to Immediate Care, Dxd cellulitis at injection site and UTE, started Keflex. On 10/08/2013 (time of reporting) symptoms are improved, inflammation site smaller; less red, less hot.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Tenderness, Urinary tract infection
Clinical narrative: Lower body ache, low fever, physical weakness and tiredness, large warm red patch at injection site.  On 10/05/2013 had fever of 103.2, body aches, red patch on arm about 5X4", red and hot.  Went to Immediate Care, Dxd cellulitis at injection site and UTE, started Keflex. On 10/08/2013 (time of reporting) symptoms are improved, inflammation site smaller; less red, less hot.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Asthenia, Fatigue, Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Body aches, "level 3 pain back to feet", urinating more than normal, temp 103.2, tender large spot on left arm/shoulder 3x4"; hot spot on arm (L), given KEFLEX for cellulitis / UTI, swelling arm/should/chest.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Body aches, "level 3 pain back to feet", urinating more than normal, temp 103.2, tender large spot on left arm/shoulder 3x4"; hot spot on arm (L), given KEFLEX for cellulitis / UTI, swelling arm/should/chest.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Back pain, Body temperature increased, Cellulitis, Injection site pain, Local swelling
Clinical narrative: Body aches, "level 3 pain back to feet", urinating more than normal, temp 103.2, tender large spot on left arm/shoulder 3x4"; hot spot on arm (L), given KEFLEX for cellulitis / UTI, swelling arm/should/chest.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pollakiuria, Skin warm, Swelling
Clinical narrative: Body aches, "level 3 pain back to feet", urinating more than normal, temp 103.2, tender large spot on left arm/shoulder 3x4"; hot spot on arm (L), given KEFLEX for cellulitis / UTI, swelling arm/should/chest.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Tenderness, Urinary tract infection
Clinical narrative: Body aches, "level 3 pain back to feet", urinating more than normal, temp 103.2, tender large spot on left arm/shoulder 3x4"; hot spot on arm (L), given KEFLEX for cellulitis / UTI, swelling arm/should/chest.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Local swelling, Skin warm
Clinical narrative: Raised red circle, surrounded by a another pink circle. Inflammed and hot to the touch.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Autopsy, Biopsy soft tissue, Death, Diarrhoea, Irritability
Clinical narrative: She started to have a fever of 100.4 about 3:00 PM on 09/16/2013.  I gave her Tylenol to lower the temperature.  She continued to have a fever off and on for the night and following day.  About 6:30 AM on 09/17/2013, she had diarrhea that leaked out of her diaper down her left leg onto her foot.  On the morning of 09/18/2013, she was cranky and fussy.  I was unable to calm her.  She even refused her pacifier that she loved.  About 11:00 AM, she was found on her back without a pulse and not breathing.  She was pronounced dead at the hospital later that day.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Pulse absent, Pyrexia, Respiratory arrest, Toxicologic test
Clinical narrative: She started to have a fever of 100.4 about 3:00 PM on 09/16/2013.  I gave her Tylenol to lower the temperature.  She continued to have a fever off and on for the night and following day.  About 6:30 AM on 09/17/2013, she had diarrhea that leaked out of her diaper down her left leg onto her foot.  On the morning of 09/18/2013, she was cranky and fussy.  I was unable to calm her.  She even refused her pacifier that she loved.  About 11:00 AM, she was found on her back without a pulse and not breathing.  She was pronounced dead at the hospital later that day.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Immediately felt itching and warmth to site - left deltoid, rapidly developed into swelling and redness diameter of a baseball; Per individual "I felt slightly lightheaded and my chest was a bit tight.  Later that day, I developed hives on my feet and toes which lasted several days.  I took 25mg Benadryl abuot 25 min after I got the shot and then I took more when I got home."  Hives lasted for 6 days and left arm was swollen for 72 hours.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Immediately felt itching and warmth to site - left deltoid, rapidly developed into swelling and redness diameter of a baseball; Per individual "I felt slightly lightheaded and my chest was a bit tight.  Later that day, I developed hives on my feet and toes which lasted several days.  I took 25mg Benadryl abuot 25 min after I got the shot and then I took more when I got home."  Hives lasted for 6 days and left arm was swollen for 72 hours.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Blood calcium normal, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: Tachycardia, shortness of breath, chest pain, dizziness, weakness.  Reported to ED at 9:20 pm, temp 100F, pulse=120, RR=20, BP=140/89, pulse ox=98%.  Patient off work until 10/14/13.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes normal, Blood glucose normal, Blood urea normal, Body temperature increased, Chest X-ray normal
Clinical narrative: Tachycardia, shortness of breath, chest pain, dizziness, weakness.  Reported to ED at 9:20 pm, temp 100F, pulse=120, RR=20, BP=140/89, pulse ox=98%.  Patient off work until 10/14/13.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dyspnoea, Full blood count normal, Lymphocyte count normal
Clinical narrative: Tachycardia, shortness of breath, chest pain, dizziness, weakness.  Reported to ED at 9:20 pm, temp 100F, pulse=120, RR=20, BP=140/89, pulse ox=98%.  Patient off work until 10/14/13.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Monocyte count normal, Neutrophil percentage increased, Tachycardia
Clinical narrative: Tachycardia, shortness of breath, chest pain, dizziness, weakness.  Reported to ED at 9:20 pm, temp 100F, pulse=120, RR=20, BP=140/89, pulse ox=98%.  Patient off work until 10/14/13.
Sex: U
Vaccine: HEP, HEPA, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. An unspecified number of doses of improperly stored vaccines: RECOMBIVAX HB (lot number and expiration date not provided), VAQTA (lot number and expiration date not provided) and GARDASIL (lot number and expiration date not provided) were exposed to temperatures as low as -2 Celsius for periods of approximately 0.5 hour might have been administered to an unspecified number of unspecified patients on unspecified dates. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Pain in jaw, Trigeminal neuralgia
Clinical narrative: This spontaneous report was received from a approximately 72 year old female patient who is also a registered nurse regarding herself. Patient's current conditions included decreased kidney function, high blood pressure, arthritis, Dermerol allergy (causes nausea), codeine allergy (causes headache), sulfur allergy ( causes ringing in the ears), Levoquin allergy (causes lockjaw), Morphine allergy and Lamisil allergy (reaction unspecified). On an unknown date in 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). Concomitant medications included Tylenol. On an unknown date in 2013, the patient experienced shingles which caused the patient pain in her trigeminal nerve and jaw. Patient had a test for temporal arthritis (results unspecified). Patient sought medical attention spoke with nurse practitioner. The patient took a Maxalt for this pain and it went away (MARRS# 1309USA012420). The patient continues to use Maxalt to relieve pain in her trigeminal nerve and jaw. The outcome of shingles was reported as not recovered. The outcome of pain in her trigeminal nerve and jaw was reported as recovered. This is one of 2 reports regarding the same patient. Additional information has been requested.
Sex: U
Vaccine: MEN, PPV
Symptoms: Body temperature increased
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. In approximately 2010 the patient was vaccianted with PNEUMOVAX23 (dose, route of administrtion and lot number were not reported) concomitatly with Meningococcal vaccine (unspecified). In approximately 2010, the patient developed a temperature 104 degrees after receiving PNEUMOVAX23. The putcome of event was unknown. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On an unknown date in October 2007, the patient was vaccinated with the first dose of COMVAX (lot number, expiry date, dose and route unspecified). On an unknown date in October 2008, the patient was vaccinated with the second dose of COMVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abscess intestinal, Colostomy, Crying, Diarrhoea, Enema administration
Clinical narrative: Onset of vomiting, diarrhea - both thick and mucosy on 9/12/13 also fussy, crying a lot, decreased urine output. PEDIALYTE 1-2 oz for every episode of loose stool - to go to ER if unresponsive or no po intake. 9-13-13 - bloody stools, green vomit told to go to ER now. At ER - admitted for intussusception - surgery required.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Intestinal perforation, Intussusception, Irritability, Platelet count increased
Clinical narrative: Onset of vomiting, diarrhea - both thick and mucosy on 9/12/13 also fussy, crying a lot, decreased urine output. PEDIALYTE 1-2 oz for every episode of loose stool - to go to ER if unresponsive or no po intake. 9-13-13 - bloody stools, green vomit told to go to ER now. At ER - admitted for intussusception - surgery required.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Surgery, Urine output decreased, Vomiting, White blood cell count increased
Clinical narrative: Onset of vomiting, diarrhea - both thick and mucosy on 9/12/13 also fussy, crying a lot, decreased urine output. PEDIALYTE 1-2 oz for every episode of loose stool - to go to ER if unresponsive or no po intake. 9-13-13 - bloody stools, green vomit told to go to ER now. At ER - admitted for intussusception - surgery required.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report has been received from a physician who was referring to his son, a 13 year old male patient with none pertinent medical history. On 04-OCT-2012 the patient was vaccinated with the first and only dose of GARDASIL (lot#not reported) dose reported as 1 vial, intramuscular. No concomitant therapies were reported. On 04-OCT-2012 the patient experienced injection site pain. The patient was treated with TYLENOL. None lab diagnosis was performed. The patient did not seek medical attention. The outcome of injection site pain was reported as recovered, on approximately on 08-OCT-2012 reported as 4 days after vaccination. The relatedness between the therapy with GARDASIL and injection site pain was not assess by the reporter. This is one of the multiple reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Culture, Herpes zoster, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On 17-SEP-2013, the patient was vaccinated with a dose of ZOATAVAX (Lot number, expiry date, route and dose were not reported) vial. Approximately on 17-SEP-2013 (at an unspecified time shortly after receiving ZOSTAVAX), the patient developed rash on thigh groin and one testicle. The patient had developed a "zoster like rash" on testicles. Patient sought medical attention and went to see unspecified dermatologist and was diagnosed with herpes zoster and was prescribed Valtrex which had not yet been started. Physician stated that the dermatologist completed a "culture" on 26-SEP-2013. Valtrex had not been started and does not plan to start. The physician who advised patient takes Embrel and unspecified rheumatologist advised ZOSTAVAX vaccination would "be alright". The outcome of the report events was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a female patient in her "mid-forties". On 17-FEB-2010 the patient was vaccinated with a dose of M-M-R II (dose, route and lot # not reported). On 17-FEB-2010, the patient experienced fever, chills and body ache for "about 10 days" (recovered approximately on 26-FEB-2010) after administration of the M-M-R II. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Left arm pain x 3 weeks, since flu shot was given on 9-19-13 at injection site and in muscle. Exam injection pain in muscle decreased ROM at shoulder.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Left side of upper lip swelled, noticed at 10pm. Still swollen next morning - did not take anything until 9 AM 10/8/13 took 4mg chlorpheniramine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Pt received regular FLUZONE 0.5 ml IM to (L) deltoid at 7:35 pm 5 mins after vaccine administered pt. states "I have a sore throat" no SOB no wheezing no swelling of lips. Pt referred EPIPEN/BENADRYL signed AMA forms.
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Did a clinic and business wouldn't disclose employee's information due to confidentiality. I was only able to find out her arm was swollen and she went to the ER to be treated. Pts received flu shot with/without Pneumo / Tdap.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Eyelid oedema, Headache, Post-tussive vomiting, Pyrexia
Clinical narrative: Within 24 hours of receiving vaccine, pt developed fever, headache, puffy eyes, cough and congestion, post tussive emesis noted, fever present for 5 days with temp high 102. Symptomatic care.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Respiratory tract congestion
Clinical narrative: Within 24 hours of receiving vaccine, pt developed fever, headache, puffy eyes, cough and congestion, post tussive emesis noted, fever present for 5 days with temp high 102. Symptomatic care.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: Employee was given flu vaccine. Reports facial swelling, difficulty breathing, hives, was evaluated in ED and treated. Rx prednisone and released to home.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 22-AUG-2012, the patient was vaccinated with the first dose of GARDASIL, dose and route not reported. On 07-OCT-2013 the patient was scheduled to receive the second GARDASIL, dose and route not reported. No symptoms reported. The patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a claims administrator, concerning a male patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # J001005, expiration date 24APR2014) along with diluent with (lot # H10635 and expiration date DECEMBER 2014). The patient had an adverse reaction (not further specified) to the ZOSTAVAX (Merck). It was unknown if the patient sought medical attention. Treatment and outcome of the adverse reaction was unknown. Additional information was requested.
Age: 32.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site warmth
Clinical narrative: Large red area away in inner arm about an inch from injection. Painful and very hot to the the touch. Started to spread and seen Dr.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Upper aspect of left hand and arm hives denies any SOB, throat irritation c/o purititis at site of hives.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Amylase increased, Computerised tomogram abdomen normal, Lipase increased, Pancreatitis
Clinical narrative: Abdominal pain and vomiting - admitted to hospital, diagnosed with pancreatitis, was discharged on 07/22/14 improved - has recovered completely.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Abdominal pain and vomiting - admitted to hospital, diagnosed with pancreatitis, was discharged on 07/22/14 improved - has recovered completely.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Patient came to pharmacy 10-8-13. Has firm nodule on right upper arm behind deltoid. She atrributes it to PNEUMOVAX given 9-5-13 but our documentation shows PNEUMOVAX given in left arm. Nodule is 1-2 cm below dermis and is 1-2 mm in diameter. Burns and painful radiates to elbow and shoulder. Not red, inflamed or warm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local swelling, Pain in extremity
Clinical narrative: Pt c/o arm swelling and soreness in same arm that she said vaccine was given. Upon evaluation, (L) arm (outer and inner) was edematous, erythematous approx 4" wide and 6" long approximately 3" below (L) deltoid. No redness or swelling was noted on deltoid area. Area warm to touch.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dry mouth, Dysphonia, Dyspnoea, Sensation of foreign body
Clinical narrative: Chest pressure, hoarse, dry mouth, feels like a knot at the base of her throat. Chest tightness, SOB, V/S 144/97 - 71 - 16 - 100% R/A.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Chest discomfort, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: Received vaccination around 0930am, states started feeling dizzy and nauseated around 1030am - states started feeling worse as day went on - c/o chest pressure, shortness of breath, fatigue, N/V, dizziness. States she had not taken AM med and ate little breakfast - seen by EMS. Skin cool and clammy to touch 1245. Dextrose stick-67 - V/S - 162/104 - 72 - 18 - /EMS V/S - 160/87 - 81 - 18. Refused to go go ER.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Received vaccination around 0930am, states started feeling dizzy and nauseated around 1030am - states started feeling worse as day went on - c/o chest pressure, shortness of breath, fatigue, N/V, dizziness. States she had not taken AM med and ate little breakfast - seen by EMS. Skin cool and clammy to touch 1245. Dextrose stick-67 - V/S - 162/104 - 72 - 18 - /EMS V/S - 160/87 - 81 - 18. Refused to go go ER.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Nausea
Clinical narrative: Received vaccination around 0930am, states started feeling dizzy and nauseated around 1030am - states started feeling worse as day went on - c/o chest pressure, shortness of breath, fatigue, N/V, dizziness. States she had not taken AM med and ate little breakfast - seen by EMS. Skin cool and clammy to touch 1245. Dextrose stick-67 - V/S - 162/104 - 72 - 18 - /EMS V/S - 160/87 - 81 - 18. Refused to go go ER.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt. reported left upper arm swollen and hot to touch. Took Band Aid off around 10 AM 10/4/13 and it got worse.
Age: 1.69
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Eye swelling, Urticaria
Clinical narrative: Pt. broke out in hives all over entire body. Severe swelling around eyes.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dyspnoea, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Fatigue, hot and cold, chills, headache, upper body aches, and some breathing problems.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Fatigue, hot and cold, chills, headache, upper body aches, and some breathing problems.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pain, Swelling face
Clinical narrative: Achiness, red bothersome eyes, face swelling.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Local swelling
Clinical narrative: C/O raised, red, dime-sized areas appear to be swollen that itch on arms bilaterally from shoulder to wrist.  A few appeared day after shots given and now have approx 30.  No heat, no s/s anaphylactic reaction, slight fever (mother unsure of exact temp on mother gave antihistamine and still itching the day following vaccinations No change in diet or contact with substance that may have caused reaction.  No history egg allergy or reaction to vaccines in past.  Child taken to ER 10/7/13 given cortisone cream (unsure name) BID x 14 days to apply to arms, Benadryl every 4 hours prn for itching.  Was told by attending health provider (unsure of name) that condition did not relate to immunizations but ruled out everything else.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Pruritus, Pyrexia
Clinical narrative: C/O raised, red, dime-sized areas appear to be swollen that itch on arms bilaterally from shoulder to wrist.  A few appeared day after shots given and now have approx 30.  No heat, no s/s anaphylactic reaction, slight fever (mother unsure of exact temp on mother gave antihistamine and still itching the day following vaccinations No change in diet or contact with substance that may have caused reaction.  No history egg allergy or reaction to vaccines in past.  Child taken to ER 10/7/13 given cortisone cream (unsure name) BID x 14 days to apply to arms, Benadryl every 4 hours prn for itching.  Was told by attending health provider (unsure of name) that condition did not relate to immunizations but ruled out everything else.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Rash macular
Clinical narrative: The skin around my ring finger became very itchy. In the afternoon, (3:00) the skin on my right wrist on underside became itchy with small red bumps about the size of a silver dollar. On 10/4, The skin on the inside of my left elbow and backside of my right knee were also itchy with red blotches. I used some hydrocortisone cream 1% to relieve some of the itchiness. As of 10/8/2013 (today) all sites remain itchy with red dots and small splotches.  It hasn't gotten worse or better.